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 15181–15200 of 38,428 recalls
Recalled Item: smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL
The Issue: A manufacturing error resulted in out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL
The Issue: A manufacturing error resulted in out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL
The Issue: A manufacturing error resulted in out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL
The Issue: A manufacturing error resulted in out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL
The Issue: A manufacturing error resulted in out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL
The Issue: A manufacturing error resulted in out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 -
The Issue: If the C-arm leaves its intended travel path
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay
The Issue: The increased level of RPR reactivity in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235 The Proton Therapy System - Proteus 235 (brand
The Issue: Signature from the user is necessary to proceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product...
The Issue: HeartStart XL MonitorlDefibrillators may not have been included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oscar 2
The Issue: The device display, when activated, can show an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
The Issue: Custom procedure kits contains affected lots of PosiFlush
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage:
The Issue: One (1) TRUE METRIX AIR blood glucose meter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an
The Issue: Internal Paddles may wear over time and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B
The Issue: Unexpected stress fractures on the shaft of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Professional Urine Drug Control
The Issue: Three products requiring refrigerated storage conditions were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS
The Issue: Unexpected stress fractures on the shaft of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B-Hydroxybutyrate LiquiColor
The Issue: Three products requiring refrigerated storage conditions were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Strep B Carrot Broth One-Step
The Issue: Three products requiring refrigerated storage conditions were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Cios Alpha VA30-mobile X-Ray system
The Issue: Main cable can be plugged or unplugged from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.