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 5, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Tribio Implant 7.5mm x 40mm Due to incorrect product label (Incorrect product name identified on outer packaging). Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall DxFLEX Flow Cytometer Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, New York, Ohio, Oregon, Tennessee and Texas named
- Medical device recall REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a… Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 26, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MONARCH Bronchoscope Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Virginia, Vermont, Washington and West Virginia named
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Collection Tube Extender Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Meridian Bioscience, alethia c The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report14 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereAlabama, Colorado, Florida, Georgia, Illinois, Maryland, Maine, Montana, New Hampshire, New Jersey, Ohio, Tennessee, Texas and Washington
- Medical device recall Meridian Bioscience, Group B Streptococcus The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report14 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereAlabama, Colorado, Florida, Georgia, Illinois, Maryland, Maine, Montana, New Hampshire, New Jersey, Ohio, Tennessee, Texas and Washington
- Medical device recall Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require… Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report28 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus… Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon… Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereAlaska, California, Iowa, Kentucky, Washington and Wisconsin
- Medical device recall Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name:… Affected catheters were reprocessed beyond validated cycles. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereKentucky, Massachusetts, Maryland, Mississippi, New Jersey, Pennsylvania, Texas and Utah
- Medical device recall Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC… Affected catheters were reprocessed beyond validated cycles. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereKentucky, Massachusetts, Maryland, Mississippi, New Jersey, Pennsylvania, Texas and Utah
- Medical device recall MAGNETOM Cima.X Upgrade There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 19, 2025ClassClass IStatusOngoingWhereCalifornia
- Medical device recall CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253,… Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Convenience Kit, BREAST HERNIA DYNJ909125G Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D… Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Anesthesia circuit kit Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Convenience kits Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Convenience kits Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 19, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carescape B450 Potential loss of monitoring on affected monitors when powered by certain batteries. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
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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