Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kansas, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, Pennsylvania, Texas, Utah and Washington
- Medical device recall Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kansas, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, Pennsylvania, Texas, Utah and Washington
- Medical device recall Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kansas, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, Pennsylvania, Texas, Utah and Washington
- Medical device recall CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is… Potential for the display processor to experience an unexpected failure. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Georgia, Idaho, Illinois, Indiana, Mississippi, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Rhode Island, Texas and Wisconsin named
- Medical device recall Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereColorado, Michigan, New Jersey, Ohio, Pennsylvania, Tennessee and Texas
- Medical device recall Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereColorado, Michigan, New Jersey, Ohio, Pennsylvania, Tennessee and Texas
- Medical device recall Olympus JF-140F duodenoscopes (Model NumberJF-140F) Issuance of validated, new reprocessing procedures. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus JF-160F duodenoscopes (Model NumberJF-160F) Issuance of validated, new reprocessing procedures. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cryovalve(R) SG Pulmonary Human Heart Valve Devices, which met FDA and AATB eligibility criteria, were distributed. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereArkansas and Ohio
- Medical device recall Cryopatch SG Pulmonary Human Cardiac Branch Devices, which met FDA and AATB eligibility criteria, were distributed. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereArkansas and Ohio
- Medical device recall Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser… In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sonialvision Safire II When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Louisiana, Michigan, New Jersey, South Carolina, Texas and Washington named
- Medical device recall cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software… The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Iowa, Indiana, Kentucky, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Texas and Virginia
- Medical device recall remel SUPERPACK CS/ 500 SEG/FLASK Product may fail performance testing for S aureus ATCC 43300. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 12C IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Proteus ONE and Proteus Plus IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as… The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry… Class IIIFDA’s classJun 20, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 20, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Louisiana, Maryland, North Carolina, New Jersey, Ohio, Oklahoma, Tennessee, Texas, Wisconsin and West Virginia
- Medical device recall IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X Five warning statements are missing from the instructions for use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report53 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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
- Medical device recall IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X Five warning statements are missing from the instructions for use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report53 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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
- Medical device recall IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X Five warning statements are missing from the instructions for use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report53 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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
- Medical device recall IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X Five warning statements are missing from the instructions for use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report53 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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
- Medical device recall STAT-Check MANUAL RESUSCITATOR / VENTILATOR There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereIllinois and Ohio
- Medical device recall Aortic Arterial Cannula 20 Fr (O.D.) This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWherePuerto Rico and Virginia
- Medical device recall Aortic Arterial Cannula 22 Fr (O.D.) This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWherePuerto Rico and Virginia
- Medical device recall Aortic Arterial Cannula 24 Fr (O.D.) This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWherePuerto Rico and Virginia
- Medical device recall Prima Plus ¿4.1 x 11.5mm Implant The implants are mislabeled. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Montana, New Jersey, Nevada, New York, Texas and Virginia
- Medical device recall smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo 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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