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 35081–35100 of 38,428 recalls
Recalled Item: Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 220/240V AC
The Issue: TCVS is taking action to update the Operators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo¿ Advanced Perfusion System 1: 220/240V AC
The Issue: The operators manual does not fully describe the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo¿ Advanced Perfusion System 1 (APS1
The Issue: Terumo Cardiovascular Systems (TCVS) has become aware that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30
The Issue: This recall has been initiated by Aspen Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DICOM Export Format for Sum Dose with Velocity v3.0.0. A
The Issue: An anomaly was detected such that, under certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027
The Issue: Review of on-system electronic product labeling and Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemoCue¿ Hb 201 Microcuvettes
The Issue: HemoCue AB has become aware of a production
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 100NX Cassettes
The Issue: The recall of the STERRAD 100NX Cassettes was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Folate (2500 tests)
The Issue: Calibration failures and/or significant negative shifts in quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Folate (500 Tests) SMN 10325366
The Issue: Calibration failures and/or significant negative shifts in quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD
The Issue: During an internal investigation, a formulation error that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Folate (500 tests)
The Issue: Calibration failures and/or significant negative shifts in quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.