Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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 Inc. is recalling ETEST Clinical Imipenem IP 32 susceptibility test kits nationwide because temperature and time storage conditions were exceeded, which may affect product performance.
Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising product performance.
Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.
Biomerieux Inc recalls BIOBALL K.RHIZOPHILA diagnostic kits (batch 7408) due to exceeded temperature and time storage conditions that may compromise product performance.
Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.
Randox Laboratories recalls a quality control product (PS2682) because Rheumatoid Factor concentration has declined, causing out-of-range quality control results and delayed laboratory test reporting.
Four Seasons Produce has recalled PROPAL Hass Avocados for containing pesticide residue that exceeds federal tolerance limits. Affected bags were distributed to consignees in New Jersey and Pennsylvania.
Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.
Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.
Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product performance.
Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of product performance.
Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.
Jubilant Cadista Pharmaceuticals recalls 14,061 bottles of Prochlorperazine Maleate 5mg tablets nationwide due to subpotency. The medication failed quality testing at 18 months and contains less active ingredient than specified.
Biomerieux Inc is recalling diagnostic culture media because temperature and time storage conditions exceeded acceptable specifications, which means product performance cannot be guaranteed.
Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.
Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.
Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory test accuracy.
Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.
Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.
Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.
Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were distributed nationwide.
Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.
Biomerieux Inc. is recalling PPM Lombard TSA culture medium nationwide due to storage temperature excursion. The product may not perform to specification.
Acumed is recalling Acutrak 2 bone screw products distributed without FDA pre-market clearance. Healthcare providers should contact Acumed or the FDA for guidance regarding use and management of these devices.
Wismettac Asian Foods recalls Shirakiku Fish Sausage due to undeclared collagen (bovine dermis) casing. Approximately 4,780 units were distributed across multiple U.S. states.