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 22921–22940 of 38,428 recalls
Recalled Item: Respire Pink+ Hard Oral Sleep Apnea Device
The Issue: for device breakage during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR
The Issue: The firm identified a labeling error affecting Made-To-Order
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ELAN 4 Air System is intended for high speed cutting
The Issue: The ELAN 4 Air System was released to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
The Issue: Incorrect DICOM mapping of the exported collimator or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AERO IOL Injection System containing 10 Z28 Cartridges per box
The Issue: The recommended storage temperature on the label is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
The Issue: There is a potential failure of the top
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II
The Issue: There is a potential failure of the top
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Amia Automated Peritoneal Dialysis Set with Cassette
The Issue: The firm received increased customer complaints for Missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LCSU 4
The Issue: A shipment of LCSU 4 suction units and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis
The Issue: The affected lots are being recalled because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis
The Issue: The affected lots are being recalled because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS
The Issue: Leakage of FMS gravity tub sets (281113) at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.via systems with SW VB20A
The Issue: A software update was released on August 22,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Cage
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Cage
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile Mini C-arm system Part # 1000-0004. Intended to provide
The Issue: OrthoScan Inc. discovered during investigation of a non-standard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide
The Issue: OrthoScan Inc. discovered during investigation of a non-standard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile Mini C-arm system Part # 1000-0001. Intended to provide
The Issue: OrthoScan Inc. discovered during investigation of a non-standard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile Mini C-arm system Part # 1000-0005. Intended to provide
The Issue: OrthoScan Inc. discovered during investigation of a non-standard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURPLUG MICRO CONNECTOR Item No. 066-C3352
The Issue: ICU Medical has identified certain stopcocks that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.