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 26401–26420 of 38,428 recalls
Recalled Item: Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray
The Issue: The infant performance test did not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.2 Micron Filter
The Issue: Baxter Healthcare Corporation is issuing a voluntary product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography
The Issue: The infant performance test did not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography
The Issue: The infant performance test did not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R&D Systems
The Issue: R&D Systems, Inc. received two customer complaints that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHS Spinal Tray 24G Gertie Marx
The Issue: Integra LifeSciences has recently identified that one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial Access Kits
The Issue: Integra LifeSciences has been notified of a medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WECK¿ Horizon" Manual-Load Ligating Clip Applier
The Issue: Misbranded: Incorrect etching on the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integral Lumbar Drainage Set
The Issue: During final sampling inspection, one of the lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Ventricular Catheter Accessory Kit
The Issue: During final sampling inspection, one of the lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Drainage Accessory Kits
The Issue: During final sampling inspection, one of the lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Straight Ventricular Catheter F8
The Issue: During final sampling inspection, one of the lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUSA Dissectron Fingertip Laparoscopic Cannula
The Issue: During final sampling inspection, one of the lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Lumbar Drainage Set
The Issue: During final sampling inspection, one of the lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The EKOS cart has the catalog number 700-60101. The EKOS
The Issue: Casters on the EKOS carts may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sertera Biopsy Device
The Issue: Incorrect label on the Sertera Biopsy Kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Introes Pocket Bougie is an endotracheal tube introducer. The
The Issue: The Introes Pocket Bougie an endotracheal tube introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panoramic X-ray Model PC-1000
The Issue: Panoramic Corporation is performing a voluntary Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor
The Issue: Stryker Orthopaedics has received reports of the thread
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Drape
The Issue: Novadaq is informing SK6000 PAQ users that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.