Drug & Device Safety Atlas

FDA recall record · openFDA

Universal Meditech Inc.

27 FDA recalls on record (2023) — 27 device. 27 still ongoing.

0
Class I (most serious)
27
Class II
0
Class III
27
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant 27

Recalls

DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 Class II 2023-05-22 PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS Class II 2023-05-22 PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 Class II 2023-05-22 DiagnosUS Pregnancy Test Midstream REF 100-17 Class II 2023-05-22 PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE Class II 2023-05-22 Lem Fertility hCG Pregnancy Urine Test REF 100-12 Class II 2023-05-22 DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Class II 2023-05-22 OMTMO One Step Ovulation (LH) Test Strips REF 200-07 Class II 2023-05-22 One Step Pregnancy Test REF 100-01 Class II 2023-05-22 HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 Class II 2023-05-22 PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips Class II 2023-05-22 DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07 Class II 2023-05-22 PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips Class II 2023-05-22 DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 Class II 2023-05-22 DiagnosUS One Step LH Ovulation Test Strip REF 200-07 Class II 2023-05-22 DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 Class II 2023-05-22 HealthyWiser UriTest" UTI Test Strips REF 900-UTI Class II 2023-05-22 DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 Class II 2023-05-22 HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP Class II 2023-05-22 DiagnosUS Ovulation Predictor Midstream REF 200-17 Class II 2023-05-22 Lem Fertility LH Ovulation Test (Strip) REF 200-07 Class II 2023-05-22 One Step Ovulation Test REF 200-01 Class II 2023-05-22 HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips Class II 2023-05-22 To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 Class II 2023-05-22 PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS Class II 2023-05-22 Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 Class II 2023-05-22 PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips Class II 2023-05-22

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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