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 22501–22520 of 38,428 recalls
Recalled Item: Radial Artery Catheterization Kit
The Issue: The povidone iodine prep pads included in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arterial Access Tray
The Issue: The povidone iodine prep pads included in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible...
The Issue: A portion of Lot 7H02242 outer boxes (market
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts
The Issue: The drill guides were manufactured with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage:
The Issue: Confirmed defect of homogeneity where some reagent vials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated
The Issue: Confirmed defect of homogeneity where some reagent vials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or
The Issue: Confirmed defect of homogeneity where some reagent vials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual
The Issue: Confirmed defect of homogeneity where some reagent vials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: fastener
The Issue: It was identified that the product was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: radial stem implant #3 (Sterile packed). Orthopedic implant for replacement
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radio Capitellum Small
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lateral Assembly
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: rHead Recon Stem Implant non-coated
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lat Assembly
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lateral Assembly
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: rHead Recon Stem Implant Plasma Coated
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: radial stem implant #1 (Sterile packed). Orthopedic implant for replacement
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lateral Assembly
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lateral Assembly
The Issue: Revision rate identified as higher than other proximal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.