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 15481–15500 of 38,428 recalls
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product
The Issue: RaySert PLUS RSP01 LOT K030 labeled with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
The Issue: Space between the device and the packaging permits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jamshidi Bone Marrow Biopsy/Aspiration Needle
The Issue: Sterility compromised due to packaging pouches that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Langston Dual Lumen Catheter 6F Model 5540. For delivery of
The Issue: The inner lumen of the Langston catheter may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
The Issue: The CORFLO PEG tube may become blocked at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncomine Dx Target Test DNA Control-IVD for detection of DNA
The Issue: Extended Expiration Date prior to clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of
The Issue: Extended Expiration Date prior to clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ion Torrent Dx No Template Control Kit- IVD for detection
The Issue: Extended Expiration Date prior to clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncomine Dx Target Test RNA Control- IVD for detection of
The Issue: Extended Expiration Date prior to clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt -
The Issue: A high frequency output (2 MHz) has not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips
The Issue: There were unknown bioburden levels prior to sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.