Manufacturer
28 recalls in our database name Universal Meditech Inc. as the manufacturing or recalling firm.
Of the 28 recalls from Universal Meditech Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (4%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.
Universal Meditech is recalling HealthyWiser KetoFast Ketone Test Strips because they were distributed without FDA authorization and lack documentation of proper manufacturing and quality control.
Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.
Universal Meditech Inc. is recalling diagnostic tests distributed without FDA authorization and lacking required quality system documentation. The company is ceasing operations and cannot fulfill post-market responsibilities.
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.
Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.
Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.
Universal Meditech Inc. is recalling DiagnosUS Pregnancy Test Midstream kits (3,304 units) due to inability to verify marketing authorization and missing quality documentation. The company, which is closing, cannot fulfill post-market safety responsibilities.
Universal Meditech Inc. is recalling DeTec hCG pregnancy test cassettes due to unverified marketing authorization and missing manufacturing documentation. Device performance characteristics cannot be confirmed.
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
Universal Meditech Inc. is recalling multiple diagnostic test products distributed without FDA authorization or documented quality system compliance. The company is unable to provide manufacturing or post-market surveillance documentation.
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
Universal Meditech Inc. recalls DiagnosUS hCG Pregnancy Test cassettes distributed in eight U.S. states due to lack of manufacturing documentation and unknown performance characteristics. The firm is going out of business.
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.
Universal Meditech Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.
Universal Meditech Inc. is recalling DiagnosUS Ovulation Predictor Midstream devices due to lack of FDA marketing authorization and inability to verify manufacturing compliance. The manufacturer is ceasing operations.
Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips because the manufacturer lacks documentation verifying manufacturing compliance and device performance. The company is ceasing operations and cannot fulfill post-market safety responsibilities.
Universal Meditech is recalling multiple diagnostic test strips distributed without FDA authorization. The company is closing and cannot provide documentation of manufacturing quality or post-market monitoring.