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 32721–32740 of 38,428 recalls
Recalled Item: Life Force Chamber Product Usage:The product is intended for restful
The Issue: The Life Force chamber is marketed and promoted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray
The Issue: Integra LifeSciences is recalling the Integra NewPort MIS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PerkinElmer Specimen Gate Screening Center software
The Issue: for demographic information and test result to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Data Manager 2.0 (Content manager 2.0
The Issue: The following defects have been identified for data
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The STERIS 4085 General Surgical Table Product Usage: is an
The Issue: STERIS engineering analysis has determined the D1 pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity¿ Four Birthing Bed
The Issue: The attachment latch mechanism can become bent depending
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solanas 2.1mm FIXED DEPTH DRILL
The Issue: Alphatec Spine is recalling the 2.1mm Fixed Depth
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esaote PA230E Transducer A portable and cart base ultrasound system
The Issue: Using the PA230E transducer with a user-defined setting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing
The Issue: Identifiers on the label are correct but the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediChoice Dual-Release Folding Walker with 5" wheel
The Issue: Product wheels may be too loose, too tight,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete
The Issue: McKesson Cardiology Hemo front-end parameter boxes must undergo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are...
The Issue: A potential splitting of the surface treatment of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a
The Issue: A potential splitting of the surface treatment of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merci Retriever Intended to restore blood flow in the neurovasculature
The Issue: Merci Retrievers were shipped to US customers past
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxygen Mask
The Issue: The case label correctly states partial rebreather but
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dental Tapered Screw-Vent Implant
The Issue: Zimmer Dental is conducting a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet
The Issue: The Aquatec¿ Fixed Backrest withstands a load of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Essential NEO
The Issue: KARL STORZ Endoscopy-America is recalling the Essential NEO
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits
The Issue: for inadvertent scalpel stick injury involving the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sonopet Ultrasonic Surgical System Console
The Issue: The firm received complaints regarding insufficient irrigation to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.