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 16621–16640 of 38,428 recalls
Recalled Item: BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm
The Issue: One lot of 3.5 mm twist drills were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Energy FX: a) original Aluminum (100-3A) b) sleek (adult and
The Issue: FDA determined that marketing claims surrounding product rendered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475
The Issue: During shipping, it is possible for the Aequalis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT cTnI cartridge
The Issue: i-STAT¿ cTnI blue cartridges may generate a higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantam 2000 Electrosurgical Generator
The Issue: for the Quantum 2000 Electrosurgery Generator, part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantam 2000 Electrosurgical Generator
The Issue: for the Quantum 2000 Electrosurgery Generator, part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantam 2000 Electrosurgical Generator
The Issue: for the Quantum 2000 Electrosurgery Generator, part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart XL+ Defibrillator/Monitor
The Issue: The rotary therapy selector switch may fail, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Scenaria Whole-body X-ray CT System
The Issue: There is a possibility that the cables to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CuattroDR System Software
The Issue: There is a potential that an image from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Levo Arm Label: LEVO ARM MIZUHO OSI
The Issue: Due to the potential for fluid ingress into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Urine Electrolyte Diluent
The Issue: for the instability of the diluents VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7% BSA (Bovine Serum Albumin)
The Issue: for the instability of the diluents VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiofrequency Grounding Pad
The Issue: Affected lots were manufactured with the protective release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada
The Issue: Limited number of syringes labeled Posiflush Experimental Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
The Issue: Limited number of syringes labeled Posiflush Experimental Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sprotte Needle
The Issue: Teleflex received the attached Medical Device Recall Notice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sprotte Needle
The Issue: Teleflex received the attached Medical Device Recall Notice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berchtold Chromophare Ceiling Mounted Surgical Light System
The Issue: The firm has become aware that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implant Direct
The Issue: Through a customer complaint and and internal investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.