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 29061–29080 of 38,428 recalls
Recalled Item: Merge Cardio with software version 10.1 LA.
The Issue: The firm, Merge Healthcare, sent out Merge HEMO
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA)
The Issue: The expiration date encoded in the UDI barcode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiesse (+) Lidocaine Injectable Implant 1.5cc
The Issue: The expiration date encoded in the UDI barcode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROLARYN Injectable Implant 1.0 cc Gel
The Issue: The expiration date encoded in the UDI barcode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniArc Pro Single incision Sling System
The Issue: The lot number on the outer carton label
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: Fresenius 132 Gallon Dry Acid Dissolution Unit
The Issue: Dissolution units and replacement motors units do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units)
The Issue: Dissolution units and replacement motors units do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For
The Issue: Dissolution units and replacement motors units do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152
The Issue: Medtronic has discovered that select lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iOS Galileo Application Version 1.1.1 or lower that programs the
The Issue: A software issue can make the foot move
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee
The Issue: Incorrect use of T-Piece resuscitators will result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
The Issue: Monitor may shut down unintentionally without restarting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Biopsy Starter Kit
The Issue: Sterility of the product cannot be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 6F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 3F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Single Lumen Embolectomy Catheter 4F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 4F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Single Lumen Embolectomy Catheter 3F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.