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 15561–15580 of 38,428 recalls
Recalled Item: Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket
The Issue: for the weld to fail at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA - Deficient VIII
The Issue: A risk of sample-to-sample cross-contamination of Emicizumab for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation standalone software treatment planning system
The Issue: Due to physical limitations of the treatment machine,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage:
The Issue: Bolts holding the longitudinal movement of catheterization tables
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage:
The Issue: Bolts holding the longitudinal movement of catheterization tables
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage:
The Issue: Bolts holding the longitudinal movement of catheterization tables
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captus 4000e Thyroid Uptake System
The Issue: It is possible that the collimators have screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens N Latex CDT Kit- IVD quantitative determination of...
The Issue: Negative bias for the carbohydrate-deficient transferrin (CDT) measurement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merits E604 Pilot Navigator Stairlift - Product Usage: To transport
The Issue: Pinion gear may disengage from track allowing lift
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReWalk Personal 6.0
The Issue: ReWalk Robotics received two complaints (one in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin PCS 3650 Software Upgrade Kit
The Issue: Internal testing of software identified software anomaly scenarios
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wallace Artificial Insemination Catheter
The Issue: Expiration date discrepancy. Marked as 5 years. Expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364
The Issue: The wall charger may not properly charge the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: uDR 596i Digital Medical X-Ray Imaging System - Product Usage:
The Issue: Two issues were identified with the stationary x-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer
The Issue: Editing an assay Test Definition and switching to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentell Hydrogel Ag 4x4
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentell Hydrogel Ag 4oz. Tube
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAVIO Soft Tissue Protector
The Issue: for the NAVIO Soft Tissue Protector to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentell Hydrogel Ag 2x2
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.