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 7941–7960 of 38,428 recalls
Recalled Item: PriMatrix Ag Fenestrated
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revize
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revize-X
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurgiMend MP
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurgiMend
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurgiMend 4.0
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PriMatrix Meshed
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurgiMend 2.0
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TissueMend
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurgiMend PRS
The Issue: out of specification endotoxin test results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: wDR 2.2 Mobile Digital Diagnostic X-Ray System
The Issue: There is a software login in issue that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BencoDental iris 5% NaF varnish
The Issue: The Iris 5% Fluoride Varnish White Mint package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrestiBio Rapid Detection Pregnancy Test Midstream 3 TESTS
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrestiBio URINALASYS TEST STRIP 10 PARAMETERS
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiagnosUS Pregnancy Test Midstream
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrestiBio KETONE TEST STRIPS 100 STRIPS/+50 FREE
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lem Fertility hCG Pregnancy Urine Test
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeTec hCG Pregnancy Urine Test Cassette Format
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMTMO One Step Ovulation (LH) Test Strips
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.