Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.
Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.
Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.
Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.
Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.
Biomerieux is recalling ETEST CLINICAL MINOCYCLINE MC 256 clinical diagnostic tests nationwide due to storage temperature exceedance that may affect test performance and reliability.
Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.
Biomerieux is recalling 47 units of the VIDAS BRAHMS Procalcitonin test system (Batch 1009301530) after determining that temperature and time exceedances compromised product performance. Affected devices may produce unreliable diagnostic results.
Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.
Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.
Biomerieux Inc. recalls 58 units of the VITEK 2 AST-XN15 Test Kit after storage temperatures exceeded safe limits. Performance cannot be guaranteed. Nationwide US distribution.
Biomerieux is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 test strips (batch 1009209480) because temperature and time storage conditions were exceeded, and product performance cannot be guaranteed.
Biomerieux Inc. is recalling ETEST CLINICAL FLUCONAZOLE FL 256 susceptibility testing kits due to storage temperature and time excursions that prevent performance verification. Affected batch 1009172020 is distributed nationwide.
Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.
Biomerieux is recalling ETEST Clinical Eravacycline ERV test kits nationwide after temperature and time storage conditions exceeded acceptable ranges, making product performance unreliable.
Sam's Club is recalling Members Mark Holiday Macarons due to potential plastic particle contamination. Approximately 148,800 units distributed in Illinois are affected.
Biomerieux Inc recalls PPM INDUSTRY COMBOURG LPT BROTH culture medium batches 2117760 and 2120100 due to temperature excursion that may compromise product performance and reliability.
Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.
Biomerieux is recalling VIDAS LH 60 diagnostic test kits nationwide due to temperature and time excursion. The affected batch's product performance cannot be guaranteed due to storage conditions exceeding acceptable parameters.
DeRoyal is recalling certain Tonsillectomy Tray lots due to potential blockage of suction ports in the integrated electrosurgical suction coagulator. The defect may prevent proper suction function during surgical procedures.
Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.
Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.
Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.
Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.
Steris Corporation is recalling VERIFY Dual Species Self-Contained Biological Indicators because some units in lot 230613 fail to consistently promote spore growth, potentially masking failed sterilization cycles.