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 22081–22100 of 38,428 recalls
Recalled Item: 3910-090-800 ASSY
The Issue: Inadvertent shipment of expired units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Made Implant System with Minimum Invasive Grower (MIG) component
The Issue: From March 2007 to October 2014, product did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix...
The Issue: The kits contained an incorrect lot of Dropper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot
The Issue: During continuous postmarket surveillance activities, we have noticed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Sigma HP Cemented Trochlea Size 1 Narrow Left
The Issue: The SIGMA¿ HP PFJ Cemented Trochlear Implants, a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue PLUS catheter
The Issue: Certain lots may be missing information at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MARS Treatment Kit
The Issue: Baxter has received customer complaints regarding leakage in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the
The Issue: Mix-up between adult and pediatrics PD catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Drill Kit which includes two drill bits
The Issue: There is a possibility that DDK2-2.4-30X Disposable Drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cocaine Metabolite MICRO-PLATE EIA
The Issue: The controls and calibrators contained within the cocaine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The humeral stems trials are packaged in a kit for
The Issue: Incidents of stem trial breakage were reported to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTO REF/KERATOMETER ARK-1s
The Issue: There is possibly a difference between the measured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System STER TROC LAG SCR 70 MM
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Trochanteric Nail System STER TROC END CAP STER TROC
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.