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 3841–3860 of 38,428 recalls
Recalled Item: SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovoHip Biolox Ball Head 32mmL NovoHip Total Hip
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000 V
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm
The Issue: Specific lots of the Chameleon PTA Balloon Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000 (dV) V
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000 U14 (MBW)
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AD-TECH Spencer Probe Depth Electrode
The Issue: Ad-Tech is recalling these A-Style SD Depth Electrodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000 (MBW) V
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000 (dV)
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AD-TECH Spencer Probe Depth Electrode
The Issue: Ad-Tech is recalling these A-Style SD Depth Electrodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating table TruSystem 7000 U (MB)
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000 (MBW)
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AD-TECH Spencer Probe Depth Electrode
The Issue: Ad-Tech is recalling these A-Style SD Depth Electrodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Operating Table TruSystem 7000 U14 (MBW) V
The Issue: The firm received customer reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name:
The Issue: To better define the drying procedures described in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Recharger Kits
The Issue: The Wireless Rechargers in the kits may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological
The Issue: Product defect where the X-ray detectable barium strip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nihon Kohden Adult Ear Clip SpO2 Sensor
The Issue: Due to oximeters not having FDA market approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor
The Issue: Due to oximeters not having FDA market approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.