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.
Town and Country Compounding is recalling 101 vials of HCG because potency testing showed 74%, below the required 80-125% range.
O'Pelle Enterprises is recalling frozen raw Egg Bagels because the label fails to declare Yellow 5, a common food dye.
BioMerieux SA is recalling NucliSENS magnetic extraction reagents because a performance drift was observed in BK virus testing for certain silica batches.
Sandoz Inc. is recalling specific lots of Donepezil Hydrochloride 10 mg tablets because they failed potency tests. The medication may not contain the full prescribed dose.
Exactech is recalling 98 Alteon Neck Preserving Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs) that identify them as different devices.
Medacta USA Inc. is recalling 82 M.U.S.T. Rods due to damaged packaging and lack of sterility assurance. The recall covers units distributed in the US and several international countries.
Endologix is updating the Instructions for Use and implementing modifications to the AFX Endovascular AAA System.
Endologix updated the Instructions for Use for the AFX Endovascular AAA System to address endoleak Type IIIB.
The Binding Site Group is recalling Digital RID Plate Readers and software because a defect may prevent the system from flagging out-of-range quality control results.
The Binding Site Group is recalling 1,002 units of the Freelite Human Lambda Free SPAPlus Kit because calibration curve activity increased over time.
Endologix is recalling the AFX2 Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.
Beckman Coulter is recalling four AutoMate 2500 Family units in Maryland to update the PC image for Windows 10 compatibility.
L. Perrigo Company is recalling 162,534 tubes of Clindamycin Phosphate and Benzoyl Peroxide Gel because a small number of tubes may contain mold on the cap.
Zimmer Biomet is recalling 36 units of ArComXL polyethylene liners because packaging labels did not match the physical product, posing a risk of surgical delay.
Safeway is recalling Signature Kitchens Tuna Chunk Light in 20 oz, 12 oz, and 5 oz sizes due to failed sensory analysis and decomposition.
Carestream Health Inc. is recalling Touch Prime and Touch Prime XE ultrasound systems due to a software error that may display incorrect measurement units.
Endologix updated the Instructions for Use and modified the AFX Endovascular AAA System. The correction applies to procedures conducted after July 2015.
Endologix is updating the Instructions for Use and making modifications to the AFX Endovascular AAA System. This applies to procedures conducted after October 2015.
The Binding Site Group is recalling 809 Optilite Freelite Lambda Free Kits because specific lots produce test results that are approximately 33% lower than expected.
Safeway is recalling 177 cases of Signature Kitchens Tuna Solid White 12 oz. cans because they failed sensory analysis and showed signs of decomposition.
Endologix is recalling 17,139 units of the AFX Endovascular AAA System to update the Instructions for Use and implement device modifications.
Endologix is recalling 34 units of the AFX Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.
Endologix is correcting cumulative clinical data reports for the AFX Endovascular AAA System and Powerlink System. This action applies to procedures conducted after June 2013.
O'Pelle Enterprises is recalling Rainbow Bagels because the labels fail to declare specific artificial food dyes.
DICOM GRID Inc. is recalling Ambra PACS software version V3.16.13.0 because a defect causes diagnostic images to appear washed out, potentially affecting image analysis.