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 34301–34320 of 38,428 recalls
Recalled Item: Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to
The Issue: Mismarked and unmarked screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PedFuse Reset Screw Inserters
The Issue: Screw inserters may not mate properly with hex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PedFuse Reset Screw Inserters
The Issue: Screw inserters may not mate properly with hex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Indus Invue Screws: IM71016-XX: 04.5mm
The Issue: Mismarked and unmarked screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pro clear(R) 1 day Sphere (o mafilcon A)
The Issue: Lots were labeled with incorrect expiration dates on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearSight(TM) Toric 1 day (ocufilcon D)
The Issue: Lots were labeled with incorrect expiration dates on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asante Comfort Infusion Set with 110cm tubing & 17mm cannula
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System
The Issue: Chest Drain tubing of of the ATS Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm
The Issue: This is an expansion of the June 2013
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs
The Issue: Reports of the infusion tubing disconnecting from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.