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 34841–34860 of 38,428 recalls
Recalled Item: Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
The Issue: Imprecision with certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoCr Head (Not distributed in the United States) Used in
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metasul¿ Head. Intended for use either with or without bone
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with...
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen¿ Femoral Component (CR-FLEX GSF POR FEM
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gender Solutions" Patello-Femoral Component
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vented Spike Adapter Product Code 2C0471
The Issue: tears in the pouch of six lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sidus" Head (Not distributed in the United States)
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natural-Knee¿ II Femoral Component
The Issue: The low density polyethylene (LDPE) bag used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Low Sorbing Infusion Set
The Issue: CareFusion is recalling the SmartSite Low Sorbing Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT Big Bore Oncology
The Issue: There are artifacts appearing on the Tracker images
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Low Sorbing Infusion Set
The Issue: CareFusion is recalling the SmartSite Low Sorbing Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Vision Mounting Arm
The Issue: When positioning the display located on top of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.