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 34501–34520 of 38,428 recalls
Recalled Item: THUNDER¿ Steerable Guidewire
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COUGAR¿ Steerable Guidewire
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProVia¿ CROSSING GUIDEWIRE
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZINGER¿ Steerable Guidewire
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTAIN HYBRID¿ Guide Wire
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THUNDER¿ Extra Support Guidewire
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zinger¿ Stainless Steel Workhorse Guidewire
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ
The Issue: for PTFE (polytetrafluroethylene) coating to delaminate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue...
The Issue: Applied Medical is conducting a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prostiva RF Therapy Hand Piece Kit
The Issue: A Hand Piece high deployment force exceeded the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VitreaCore¿ software. Versions subject to the limitation: 6.0
The Issue: Vital Images, Inc. has found an issue in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Vision System Cart
The Issue: Intuitive has identified that the metalized coating on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
The Issue: Product has the potential to have a clear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PedFuse Reset Screw
The Issue: During routine servicing, it was discovered that one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile
The Issue: The firm discovered that unlatching can occur when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterrad 100NX
The Issue: Advanced Sterilization Products (ASP) is recalling the Sterrad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP...
The Issue: Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 15 L Cycler Drainage Bag Product Usage: For use with
The Issue: The large tube clamp used to close the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Na+ Slides
The Issue: Ortho Clinical Diagnostics has recalled VITROS Chemistry Products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 2
The Issue: Ortho Clinical Diagnostics has recalled VITROS Chemistry Products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.