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 7961–7980 of 38,428 recalls
Recalled Item: One Step Pregnancy Test
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrestiBio Ovulation Strips 60 LH Test Strips
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiagnosUS¿ One Step FSH Menopausal Test (Strip)
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrestiBio Ovulation and Pregnancy Strips and
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiagnosUS 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: DiagnosUS One Step LH Ovulation Test Strip
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiagnosUS hCG Pregnancy Serum/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: HealthyWiser UriTest" UTI Test Strips
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiagnosUS hCG Pregnancy Urine Test Strip Format
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips 120 STRIP
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiagnosUS Ovulation Predictor Midstream
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 LH Ovulation Test (Strip)
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: One Step Ovulation Test
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HealthyWiser KetoFast" Ketone Test Strips 150 test strips
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: To Life hCG Pregnancy Urine Test Strips Format No: 100-10
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrestiBio BREAST MILK ALCOHOL TEST STRIP 25 TESTS
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Am I Pregnant? One Step HCG Pregnancy 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 Pregnancy Strips 25 HCG Test Strips
The Issue: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis CII Safe
The Issue: Automated dispensing cabinet devices plugged into any multi-socket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.