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 33241–33260 of 38,428 recalls
Recalled Item: NexGen Complete Knee Solution
The Issue: Zimmer is initiating a voluntary recall of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution
The Issue: Zimmer is initiating a voluntary recall of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution
The Issue: Zimmer is initiating a voluntary recall of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Complete Knee Solution
The Issue: Zimmer is initiating a voluntary recall of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shaver Handpiece Sterilization Tray. Model number 272-700-000. For...
The Issue: STERRAD 100S parameters provided in the Shaver Handpiece
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accell Evo3C Demineralized Bone Matrix
The Issue: This lot of Accell Evo3C Demineralized Bone Matrix,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VerSys¿ Hip System
The Issue: During routine inspection, beaded hip stem forgings received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser...
The Issue: Laser Aperture label was not applied to certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number
The Issue: Alcon CUSTOM-PAK which is supposed to contain a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manual Resuscitator Bag Series: AF1000
The Issue: The pop-off valve in the defective devices remain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Taut Operative Cholangiogram Catheter
The Issue: Several complaints were received for the metal support
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific Chemistry Controls Level I and II LEVl: Amber
The Issue: The original mean assigned to the control too
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Temperature Ablation Catheter
The Issue: Some units of Intella Tip MiFi XP Temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended
The Issue: An update to the Virtual Simulation software of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa" Flu A/B & RSV Direct
The Issue: Focus Diagnostics is providing an urgent safety notice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DISCOVERY ELBOW prosthesis
The Issue: Surface finish is different than specified. The implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T
The Issue: Ingenia customers have experienced clamping of the foot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Spine
The Issue: The Cypher MIS Screw Inserter may exhibit an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Temperature Ablation Catheter
The Issue: Some units of Intella Tip MiFi XP Temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.