Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall 8MM, ROUND TIP SCISSORS, IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,DEBAKEY FORCEPS,IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,CADIERE FORCEPS,IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,PROGRASP FORCEPS,IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,RESANO FORCEPS,IS4000 ¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MEGA NEEDLE DRIVER,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,TENACULUM FORCEPS,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,DUAL BLADE RETRACTOR,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MEGA SUTURECUT ND,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,SMALL GRASPING RETRACTOR,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,FORCE BIPOLAR,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,LONG TIP FORCEPS,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,CADIERE FORCEPS,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,PROGRASP FORCEPS,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MICRO BIPOLAR FORCEPS,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,COBRA GRASPER,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,MEGA SUTURECUT ND,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,CURVED BIPOLAR DISSECTOR,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,LONG BIPOLAR GRASPER,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM,FORCE BIPOLAR,IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Welch Allyn, Inc., Life 2000 Ventilation System There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Welch Allyn, Inc., Life2000 Ventilation System There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Welch Allyn, Inc., Life2000 Ventilation System There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Breathe Technologies, Inc., Life2000 Ventilation System There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Infinia I GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Brivo NM 615 GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Discovery NM 630 GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Discovery NM/CT 670 GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Discovery NM/CT 670 DR GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Discovery NM/CT 670 PRO GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Discovery NM/CT 670 ES GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Discovery NM/CT 670 CZT GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Optima NM/CT 640 GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Infinia II GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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