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 31421–31440 of 38,428 recalls
Recalled Item: IR remote control JUX
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cable remote control JUC
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IR remote control JUC
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IIR remote control JUPITER
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IR remote control JUPITER / TS7500
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (R)IR remote control JUPITER
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cable remote control JUPITER
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing...
The Issue: The firm discovered that during the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTH8 Rotor
The Issue: Iris International is recalling the RTH8 Rotor used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips
The Issue: The manufacturing dates and expiration dates were transposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide
The Issue: During cleaning, two separate units of the NexGen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Linear Accelerator: ARTISTE
The Issue: Use of any unauthorized third-party components on Siemens
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification
The Issue: After receiving a complaint, Biomet Orthopedic Inc., conducted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number
The Issue: After receiving a complaint, Biomet Orthopedic Inc., conducted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERO Linear Accelerator System
The Issue: Software Anomaly. The VERO MHI-TM2000 Operator Console may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXp Tibial Insert
The Issue: Difficulty locking EXp tibial inserts into tibial trays,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult AirLife dual-limb
The Issue: Manufacturing error in humidification chamber may cause an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant AirLife single-limb
The Issue: Manufacturing error in humidification chamber may cause an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant AirLife Dual-
The Issue: Manufacturing error in humidification chamber may cause an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification...
The Issue: Manufacturing error in humidification chamber may cause an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.