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 2561–2580 of 38,428 recalls
Recalled Item: Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) PERI GYN PACK
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: to RES
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) BASIC CATARACT
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) PAIN PACK
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) INTUBATION TRAY
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) PRECIP TRAY
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) DR. KHAN
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe
The Issue: During some clinical cases, it has been observed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter NovumIQ Syringe INFUSION SYSTEM
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder Stem
The Issue: Five complaints received where surgeon was unable to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monterey AL Implant Inserter
The Issue: for the gold unlock button to separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoroptor VRx Digital System Model Numbers: 16241
The Issue: The head of the phoropter head could come
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoroptor VRx Digital System Model Numbers: 16242
The Issue: The head of the phoropter head could come
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monterey AL Implant Inserter
The Issue: for the gold unlock button to separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.