--- title: "Universal Meditech Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Universal Meditech Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/universal-meditech-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Universal Meditech Inc. recall records **28** reported ongoing 28 records in this archive. Latest source date May 22, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 22, 2023 FDA device enforcement ### [One Step Pregnancy Test REF 100-01](https://isitonrecall.com/recall/fda-device-z-0042-2024-one-step-pregnancy-test-ref-100-01/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for One Step Pregnancy Test REF 100-01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0042-2024%22) May 22, 2023 FDA device enforcement ### [One Step Ovulation Test REF 200-01](https://isitonrecall.com/recall/fda-device-z-0043-2024-one-step-ovulation-test-ref-200-01/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for One Step Ovulation Test REF 200-01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0043-2024%22) May 22, 2023 FDA device enforcement ### [HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10](https://isitonrecall.com/recall/fda-device-z-0044-2024-healthywiser-uritest-10-parameter-reagent-test-strips-for-urinalysis-ref-900-10/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0044-2024%22) May 22, 2023 FDA device enforcement ### [HealthyWiser UriTest" UTI Test Strips REF 900-UTI](https://isitonrecall.com/recall/fda-device-z-0045-2024-healthywiser-uritest-uti-test-strips-ref-900-uti/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for HealthyWiser UriTest" UTI Test Strips REF 900-UTI](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0045-2024%22) May 22, 2023 FDA device enforcement ### [HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips](https://isitonrecall.com/recall/fda-device-z-0046-2024-healthywiser-ketofast-ketone-test-strips-ref-900-1k-150-test-strips/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0046-2024%22) May 22, 2023 FDA device enforcement ### [HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP](https://isitonrecall.com/recall/fda-device-z-0047-2024-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, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0047-2024%22) May 22, 2023 FDA device enforcement ### [DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13](https://isitonrecall.com/recall/fda-device-z-0048-2024-detec-hcg-pregnancy-urine-test-cassette-format-reg-cat-100-13/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0048-2024%22) May 22, 2023 FDA device enforcement ### [Am I Pregnant? One Step HCG Pregnancy Test REF 100-17](https://isitonrecall.com/recall/fda-device-z-0049-2024-am-i-pregnant-one-step-hcg-pregnancy-test-ref-100-17/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for Am I Pregnant? One Step HCG Pregnancy Test REF 100-17](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0049-2024%22) May 22, 2023 FDA device enforcement ### [To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10](https://isitonrecall.com/recall/fda-device-z-0050-2024-to-life-hcg-pregnancy-urine-test-strips-format-ref-cat-no-100-10/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0050-2024%22) May 22, 2023 FDA device enforcement ### [PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS](https://isitonrecall.com/recall/fda-device-z-0051-2024-prestibio-breast-milk-alcohol-test-strip-ref-910-10-25-tests/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0051-2024%22) May 22, 2023 FDA device enforcement ### [PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips](https://isitonrecall.com/recall/fda-device-z-0052-2024-prestibio-ovulation-strips-ref-200-4-60-lh-test-strips/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0052-2024%22) May 22, 2023 FDA device enforcement ### [PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips](https://isitonrecall.com/recall/fda-device-z-0053-2024-prestibio-ovulation-and-pregnancy-strips-ref-100-4-and-ref-200-4-60-lh-test-strips-30-hcf-test-strip/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0053-2024%22) May 22, 2023 FDA device enforcement ### [PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips](https://isitonrecall.com/recall/fda-device-z-0054-2024-prestibio-pregnancy-strips-ref-100-4-25-hcg-test-strips/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0054-2024%22) May 22, 2023 FDA device enforcement ### [PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS](https://isitonrecall.com/recall/fda-device-z-0055-2024-prestibio-rapid-detection-pregnancy-test-midstream-ref-100-17-3-tests/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0055-2024%22) May 22, 2023 FDA device enforcement ### [PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE](https://isitonrecall.com/recall/fda-device-z-0056-2024-prestibio-ketone-test-strips-ref-900-1ket-100-strips-50-free/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0056-2024%22) May 22, 2023 FDA device enforcement ### [PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10](https://isitonrecall.com/recall/fda-device-z-0057-2024-prestibio-urinalasys-test-strip-10-parameters-ref-900-10/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0057-2024%22) May 22, 2023 FDA device enforcement ### [DiagnosUS One Step LH Ovulation Test Strip REF 200-07](https://isitonrecall.com/recall/fda-device-z-0058-2024-diagnosus-one-step-lh-ovulation-test-strip-ref-200-07/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for DiagnosUS One Step LH Ovulation Test Strip REF 200-07](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0058-2024%22) May 22, 2023 FDA device enforcement ### [DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10](https://isitonrecall.com/recall/fda-device-z-0059-2024-diagnosus-sars-cov-2-antibody-igg-igm-test-ref-555-10/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0059-2024%22) May 22, 2023 FDA device enforcement ### [DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07](https://isitonrecall.com/recall/fda-device-z-0060-2024-diagnosus-one-step-fsh-menopausal-test-strip-ref-210-07/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0060-2024%22) May 22, 2023 FDA device enforcement ### [Lem Fertility hCG Pregnancy Urine Test REF 100-12](https://isitonrecall.com/recall/fda-device-z-0061-2024-lem-fertility-hcg-pregnancy-urine-test-ref-100-12/) Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is... Class II Reported ongoing Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan [Official source for Lem Fertility hCG Pregnancy Urine Test REF 100-12](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0061-2024%22) ## Reasons in these listed records - Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their t... These examples come from this result page and are not a ranking of every recall reason. ## Checking Universal Meditech Inc. ### Is there a recall on universal meditech inc. right now? This archive contains 28 records, including 28 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Universal Meditech Inc.](https://isitonrecall.com/check/?q=Universal%20Meditech%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)