Universal Meditech Inc.
Complete recall history across all FDA and CPSC categories — 28 total recalls
Universal Meditech Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (28)
FDA medical device enforcement actions by Universal Meditech Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 22, 2023 | PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | One Step Ovulation Test REF 200-01 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | Lem Fertility LH Ovulation Test (Strip) REF 200-07 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | DiagnosUS Ovulation Predictor Midstream REF 200-17 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| 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 Al... | Class II |
| May 22, 2023 | DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | HealthyWiser UriTest" UTI Test Strips REF 900-UTI | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | DiagnosUS One Step LH Ovulation Test Strip REF 200-07 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| 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 Al... | Class II |
| May 22, 2023 | DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | One Step Pregnancy Test REF 100-01 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | OMTMO One Step Ovulation (LH) Test Strips REF 200-07 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | Lem Fertility hCG Pregnancy Urine Test REF 100-12 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | DiagnosUS Pregnancy Test Midstream REF 100-17 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| May 22, 2023 | DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Al... | Class II |
| 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 approva... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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