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 34101–34120 of 38,428 recalls
Recalled Item: Zimmer Segmental Systems
The Issue: After evaluation of 13 complaints(0.4% rate) for hyper-extension
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Segmental Systems
The Issue: After evaluation of 13 complaints(0.4% rate) for hyper-extension
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Weck
The Issue: Sterility cannot be guaranteed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Locking Cortical Screw 3.5mmX38mm
The Issue: 3.5mmx38mm Locking Cortical Screw, implants are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Weck
The Issue: Sterility cannot be guaranteed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: On Site Gas Systems POGS 33C Portable Oxygen Generation System
The Issue: Heat exchanger hose becomes weak and may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled
The Issue: break in the connector of the Force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Specialty Straight Static Inserter Assembly Product Usage: This instrument is
The Issue: Stryker has received complaints from customers relating to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TopCare Clifford THE BIG RED DOG power toothbrush for kids!
The Issue: Ranir, LLC is recalling all lots of Up
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN
The Issue: ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN
The Issue: ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control
The Issue: HORIBA Medical is informing all ABX PENTRA Urine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Assist RAD BOARD
The Issue: Merit Medical Systems, Inc. is voluntarily recalling one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UP & UP kids' power toothbrush
The Issue: Ranir, LLC is recalling all lots of UP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm
The Issue: Extractor Pro XL Retrieval Balloon Catheters may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm
The Issue: Extractor Pro XL Retrieval Balloon Catheters may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm
The Issue: Extractor Pro XL Retrieval Balloon Catheters may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine
The Issue: Bicarbonate Jug Adapter distributed prior to 510(k) approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated
The Issue: An overflow flag //// is displayed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball
The Issue: Some carbide cutting burr fractured during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.