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.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DAT Performance Verifier II because storage labeling errors may cause lower than expected VITROS BENZ results.
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling may cause lower than expected test results.
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Siemens Medical Solutions is recalling Artis Q and Q.Zen systems due to a potential for liquid entry.
Avid Medical is recalling 160 GYN laparoscopy kits because they may contain needles with loose polypropylene foreign material.
Zimmer Biomet is recalling 885 Ziptight Ankle Syndesmosis Fixation Devices because they were packaged without tip protectors.
Avid Medical is recalling obstetrical convenience kits because some contain needles with loose polypropylene foreign material above release specifications.
Divine Living is recalling Silver with harmonically structured frequencies because the product contained unauthorized dietary and health claims.
Medline Industries is recalling 67,104 bottles of Povidone-Iodine Scrub Solution because the product failed to meet required iodine levels.
Allergan is recalling INFeD (Iron Dextran Injection USP) because stability testing showed the product did not meet specifications for iron content.
Schmidt Baking Co. is recalling 100% Wheat bread products due to a potential foreign material in an ingredient supplied by a vendor.
Schmidt Baking Co. is recalling Honey Wheat bread products sold under multiple trade names due to a potential foreign material in an ingredient supplied by a vendor.
Teleflex Medical is recalling Rusch Greenlite MAC 1 devices because some pouches may contain the incorrect product size, specifically MAC 2 instead of MAC 1.
Alcon is voluntarily recalling 300 units of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.
Schmidt Baking Co. is recalling various white bread products sold under multiple trade names due to a potential foreign material issue in an ingredient.
Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Alcon is recalling specific lots of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.
Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.
Accord Media, LLC is recalling 30 units of the Truth Renew device because it uses an unapproved green LED light to treat hyperpigmentation.
Avid Medical is recalling 24 knee arthroscopy kits because they may contain needles with loose polypropylene foreign material.
Schmidt Baking Co. is recalling specific lots of Premium Hams because a vendor ingredient is under recall, posing a potential foreign material hazard.
Schmidt Baking Co. is recalling wheat bread products under various trade names due to a potential foreign material in an ingredient supplied by a vendor.
Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.