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 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.
Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.
Biomerieux Inc is recalling Gene-Up Lysis Kit (Catalog 414057) because storage conditions were exceeded and product performance cannot be guaranteed. Nationwide distribution.
Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.
Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.
Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.
Biomerieux Inc is recalling VITEK 2 Reagent AST-GN73 test kits nationwide because they were stored outside proper temperature and time ranges, potentially compromising test accuracy.
Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA due to temperature and time excursions that may prevent product performance guarantees. No illnesses reported.
Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.
Steris Corporation is recalling 338 boxes of VERIFY Dual Species Biological Indicators (Lot #230613) because some units fail to promote spore growth as intended, risking false-negative sterilization test results.
Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.
Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's performance.
Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.
Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.
Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.
Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.
Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.
Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.
Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.
Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.
P.J. Salvage is recalling about 2,650 children's pajama sets that fail to meet federal flammability standards for sleepwear, posing a risk of burn injuries to children.
Quality Bicycle Products is recalling carbon handlebars and bicycles because the handlebars can crack where brake and shift levers are installed, posing a crash and injury risk. The company has received 37 reports of cracking but no injuries have been reported.
Adventurer LP is recalling 2021-2022 truck bed campers because improper thread depth on LPG tank service valves may cause propane leaks, increasing fire risk.
Hikma Pharmaceuticals recalled Ganciclovir for Injection due to a labeling error where one vial per carton was mislabeled as Cladribine Injection, creating a risk of incorrect medication administration.