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 8301–8320 of 38,428 recalls
Recalled Item: BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in
The Issue: Drill guides might bend when axial forces are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft
The Issue: Drill guides might bend when axial forces are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Betta Link LG Reusable ProngED Guide - Intended for use
The Issue: Drill guides might bend when axial forces are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft
The Issue: Drill guides might bend when axial forces are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft
The Issue: Drill guides might bend when axial forces are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoassay Premium Level 3-In vitro diagnostic use
The Issue: Delay in reporting results due to Quality Controls
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoassay Premium Control Tri Level-In vitro diagnostic use
The Issue: Delay in reporting results due to Quality Controls
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended
The Issue: Complaints on clip deployment occurring during clinical procedures,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for
The Issue: Complaints on clip deployment occurring during clinical procedures,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended
The Issue: Complaints on clip deployment occurring during clinical procedures,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for
The Issue: Complaints on clip deployment occurring during clinical procedures,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
The Issue: The digital IFUs provided with the Cardiosave IABP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE THERAHONEY GEL
The Issue: Medline issued a recall on TheraHoney Wound Gel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOxBOXi Nitric Oxide Delivery System
The Issue: Device may experience malfunctions due to misalignment of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exeter V40 Trial Head
The Issue: The Exeter V40 Trial Head, catalog number 6364-8-026
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants
The Issue: for the incorrect size stent-graft than the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGACY SMARTBASE
The Issue: Non-engaging abutments were distributed without FDA clearance; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy
The Issue: The inner needle of the Sertera device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V-Sign Sensor 2
The Issue: The sensors may experience an out-of-box failure because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Serrated Blade Applicator Kit (12 Sample)
The Issue: Packaging for a serrated blade applicator kit (12
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.