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. Source coverage and dates.

Records and reported status

FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF 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 IIReported 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...
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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
FDA device enforcement

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 IIReported 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

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 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 and the agency's current notices.

Where can I find older records?

Use monthly 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.

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