Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 17201–17220 of 38,428 recalls
Recalled Item: AggreGuide A-100 Instrument
The Issue: The firm identified a software design issue where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammomat Revelation with software version VC10 and Biopsy Option Intended
The Issue: An error can occur when performing a biopsy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module:
The Issue: Inaccurately Low Sample Results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190
The Issue: Inaccurately Low Sample Results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
The Issue: Prolonged clotting times
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTEM ex-tem Canada Part No: 503-05-CA
The Issue: Prolonged clotting times
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTEM ex-tem
The Issue: Prolonged clotting times
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNIlife science
The Issue: Acetabular liners failed the oxidation testing performed prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNIlife science
The Issue: Acetabular liners failed the oxidation testing performed prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNIlife science
The Issue: Acetabular liners failed the oxidation testing performed prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate
The Issue: Homocysteine Assay May Cause Elevated Results in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate
The Issue: Homocysteine Assay May Cause Elevated Results in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Folate (500 Test Kit )- for IVD
The Issue: Homocysteine Assay May Cause Elevated Results in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay
The Issue: Assay files used on the open Dynex DSX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge MCC Flow i Disposable CO2 absorber
The Issue: Reversed expiration and manufacturing date on the label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Enteral Safe Feeding Tubes: a)
The Issue: Certain MED-RX Polyurethane Feeding Tubes are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NobelActive Internal NP 3.5x15mm Endosseus dental implant
The Issue: The top label for dental implant may incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: Complaints have been received regarding difficulty in removing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: Complaints have been received regarding difficulty in removing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aestiva 7900
The Issue: Certain Aespire and Aestiva Anesthesia Systems were noted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.