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 14841–14860 of 38,428 recalls
Recalled Item: CMExpress Microbore Sets
The Issue: Infusion administration sets may have a delivery inaccuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMExpress Microbore Sets
The Issue: Infusion administration sets may have a delivery inaccuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BodyGuard Microset
The Issue: Infusion administration sets may have a delivery inaccuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BodyGuard Microset
The Issue: Infusion administration sets may have a delivery inaccuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BodyGuard Microset w/ Non-Vented Spike Connector
The Issue: Infusion administration sets may have a delivery inaccuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Processor SP with assay Luminex
The Issue: An instrument failure mode that may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Processor SP with assay: Luminex
The Issue: An instrument failure mode that may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The
The Issue: During internal testing execution of the next generation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
The Issue: Smiths Medical became aware that one (1) lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ion Catheter Reprocessing Cover
The Issue: One type of the ION Catheter Reprocessing Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ION Reprocessing Accessories Kit
The Issue: One type of the ION Catheter Reprocessing Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nuvasive NVM5 EMG Module
The Issue: The NVM5 EMG Module kit intended for intraoperative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU
The Issue: Lots of size 8-0 Blue twisted Silk Suture
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leksell Vantage Stereotactic System
The Issue: The locking mechanism at the interface of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Expansion Control Overlay
The Issue: QC inspection observed that a portion of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enVista one-piece hydrophobic acrylic toric intraocular lens
The Issue: The toric axis marks were misaligned (from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.8mm Truss Wire
The Issue: 1.8mm truss wires are being removed to facilitate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accurian RF Ablation
The Issue: Insertion difficulty of the probes. The probe was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accurian RF Ablation
The Issue: Insertion difficulty of the probes. The probe was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.