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.
Zimmer Biomet is recalling sterile intramedullary implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Pharmedium Services is recalling 60 bags of Vancomycin HCl injection because the label incorrectly states 500 mL instead of the actual 300 mL volume.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Pentax of America Inc is recalling 1,701 video bronchoscopes due to loose suction arms. The action retrospectively documents corrections made in 2010-2011.
Biomerieux Inc is recalling VITEK 2 Yeast identification cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Zimmer Biomet is recalling 87 units of sterile implants because packaging design verification tests failed. The action covers domestic and international distribution.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may allow moisture exposure, leading to antibiotic degradation and loss of potency.
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Cook Inc. is recalling 178 Clarke-Reich Laparoscopic Knot Pushers because the reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.