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 17081–17100 of 38,428 recalls
Recalled Item: Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN:
The Issue: The assigned value for Rheumatoid Factor over recovers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN:...
The Issue: The assigned value for Rheumatoid Factor over recovers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus XR/a (SlOK : K993090)
The Issue: Intermittently not receiving an audible exposure indication upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline SYRINGE
The Issue: Samples in the identified lot were found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Gastronintestinal (GI) Panel
The Issue: Complaints have been received concerning elevated rates of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQURE basic sytem
The Issue: The firm has become aware that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FoundationOne CDx test report
The Issue: Identified potential false positive MSI-H on the test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Superset with 22MM ID
The Issue: The port may crack in the swivel elbow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Swivel Elbow with Bronchoscopy Port 15MM OD
The Issue: The port may crack in the swivel elbow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Swivel Elbow with Bronchoscopy Port 15MM OD
The Issue: The port may crack in the swivel elbow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Superset with 22MM ID
The Issue: The port may crack in the swivel elbow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM - Product Usage: Instrument intended for
The Issue: possibility of the sterility batch being insufficiently sterilized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM Product Usage: Instrument intended...
The Issue: possibility of the sterility batch being insufficiently sterilized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Jarit GEMINI CLAMP 9 1/4 inch - used in
The Issue: A small crack at the box lock corner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BodyGuardian Heart Remote Monitoring Kit
The Issue: The device data being collected and transferred to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kiwi Complete Vacuum Delivery System
The Issue: There is a potential for loss of vacuum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp
The Issue: The potential that the end of the shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard
The Issue: Products may contain the incorrect banner card within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization
The Issue: Products may contain the incorrect banner card within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Micra MC1VR01
The Issue: Medtronic is updating the Micra Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.