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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

Clear
DateProductReasonClassFirm
Nov 22, 2025 Vivoo Vaginal pH Test Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Menopause Test Cassette (Urine) Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 LH One Step Ovulation Test Device (Urine) Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Vivoo pH Test Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED ... Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 S. Typhi/Para Typhi A Antigen Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PA... Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Vivoo Protein Test Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Exploro Highly Sensitive Male Fertility / Sperm Concentration Test Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Male Fertility Sperm Test for Home Use (Cassette) Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.

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.