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 11341–11360 of 38,428 recalls
Recalled Item: Philips Allura Xper
The Issue: Due to a leak in the detector cooling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a
The Issue: Due to a leak in the detector cooling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Radiotherapy System - System Label: "*** REF
The Issue: Due to dose discrepancy when delivering a plan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DBB-06 Hemodialysis Delivery System
The Issue: Device lacks premarket approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triathlon Pro Tibial Preparation Tray
The Issue: Triathlon Pro Tibial Preparation Tray may have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Sensis
The Issue: Software error which affects Sensis Vibe Hemo, Sensis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALLARD* Multi-Access Port Catheter
The Issue: Product was distributed with incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALLARD* Multi-Access Port (MAP) Catheter
The Issue: Product was distributed with incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement
The Issue: Product was distributed with incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
The Issue: Lower than expected results for VITROS¿ Immunodiagnostic Products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electri-Cool II Portable Cold Therapy Unit
The Issue: This recall has been initiated to provide a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar)
The Issue: The U-channel sheaths may cause damage to ProACT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WIRION EMBOLIC PROTECTION SYSTEM
The Issue: Under certain circumstances, the WIRION filter assembly may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAcube Connect MDx
The Issue: During the "Load tip racks and enzymes" step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Distractor Rack
The Issue: Two lots of the 5598007 Distractor Rack which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ki Mobility
The Issue: The Instructions for Use provided with the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Edge Plus-Computed tomography system Model 1026700
The Issue: Software version VB20_SP5 my lead to a relevant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS-Computed tomography system Model 8098027
The Issue: Software version VB20_SP5 my lead to a relevant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge -Computed tomography system Model 10590000
The Issue: Software version VB20_SP5 my lead to a relevant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Confidence -Computed tomography systems Model 10590100
The Issue: Software version VB20_SP5 my lead to a relevant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.