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 14321–14340 of 38,428 recalls
Recalled Item: Discovery NM 630 Model # H3101RH
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM/CT 870 DR Model # H3100AS
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery NM670 Pro Model # H3100XB
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM/CT 870 CZT Model # H3906CW
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM 830 Model # H3910AC
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery 670 DR Model # H3100BT
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM/CT 860
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia S-Series and Symbia T-Series - Product Usage: Intended use
The Issue: This letter is to inform you of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture
The Issue: false negative or false positive results. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product
The Issue: Masks processed at one site were not maintained
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP
The Issue: Due to non-surgical isolation gowns not meeting all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra/Phonic Focus BP Conforming Gel Pads
The Issue: The firm registered the product as a Class
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker IsoAir 2.0 support surface-provides pressure redistribution and is...
The Issue: Connector between support surface and pump may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Universal Loading Unit
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm
The Issue: The device staples may not properly form upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.