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Browse Device Recalls

28 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 28 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 28 FDA device recalls.

Clear
DateProductReasonClassFirm
May 22, 2023 PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 One Step Ovulation Test REF 200-01 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Lem Fertility LH Ovulation Test (Strip) REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS Ovulation Predictor Midstream REF 200-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser UriTest" UTI Test Strips REF 900-UTI Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS One Step LH Ovulation Test Strip REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test S... Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 One Step Pregnancy Test REF 100-01 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 OMTMO One Step Ovulation (LH) Test Strips REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Lem Fertility hCG Pregnancy Urine Test REF 100-12 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS Pregnancy Test Midstream REF 100-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
Nov 28, 2022 Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tes... Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emer... Class I Universal Meditech Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.