[ FDA ENFORCEMENT INTELLIGENCE ]

Learn from the record. Every FDA recall is a quality signal.

Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.

1,000

Total recalls

217

Class I (most serious)

167

Drug

515

Device

318

Food / supplement / cosmetic

Last 12 months · latest report 2026-07-22 · source: openFDA enforcement

RECALLS BY CLASSIFICATION · MONTHLY

RECALL REASONS BY QUALITY DOMAIN

Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.

409 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1639-2026	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1642-2026	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1610-2026	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1643-2026	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1613-2026	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1640-2026	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1612-2026	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1611-2026	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1638-2026	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1644-2026	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.	Risk Management & CAPA
2026-04-01	Class II	Olympus Corporation of the AmericasZ-1641-2026	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.	Risk Management & CAPA
2026-04-01	Class II	Mangalm LLCH-0628-2026	Potential adulteration with erucic acid from mustard oil ingredient.	Risk Management & CAPA
2026-04-01	Class II	Mangalm LLCH-0629-2026	Potential adulteration with erucic acid from mustard oil ingredient.	Risk Management & CAPA
2026-04-01	Class II	Mangalm LLCH-0624-2026	Potential adulteration with erucic acid from mustard oil ingredient.	Risk Management & CAPA
2026-04-01	Class II	Mangalm LLCH-0626-2026	Potential adulteration with erucic acid from mustard oil ingredient.	Risk Management & CAPA
2026-04-01	Class II	Mangalm LLCH-0625-2026	Potential adulteration with erucic acid from mustard oil ingredient.	Risk Management & CAPA
2026-04-01	Class II	Mangalm LLCH-0627-2026	Potential adulteration with erucic acid from mustard oil ingredient.	Risk Management & CAPA
2026-03-25	Class II	ConvaTec, IncZ-1583-2026	Drainable large pouch may leak due to manufacturing issue.	Risk Management & CAPA
2026-03-25	Class II	BlueFrog FoodsH-0578-2026	No process authority	Risk Management & CAPA
2026-03-25	Class II	ConvaTec, IncZ-1582-2026	Drainable large pouch may leak due to manufacturing issue.	Risk Management & CAPA
2026-03-25	Class II	BlueFrog FoodsH-0577-2026	No process authority	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0378-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0363-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0377-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0359-2026	CGMP Deviations	Risk Management & CAPA

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Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.