[ 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.

758 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-07-01	Class II	Medtronic Perfusion SystemsZ-2577-2026	During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2592-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Zimmer, Inc.Z-2578-2026	Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2585-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Medtronic Perfusion SystemsZ-2575-2026	During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2587-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2591-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class II	Philips North America LlcZ-2522-2026	Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.	Documentation & Change Control
2026-07-01	Class II	Central Admixture Pharmacy Services, Inc.D-0618-2026	Incorrect product formulation: bag did not contain copper and famotidine per label.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2590-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-07-01	Class I	George J Howe Company, Inc.H-1121-2026	The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.	Documentation & Change Control
2026-07-01	Class II	Alb-USA Enterprises IncH-1110-2026	Undeclared colors (FD&C Yellow 5 and FD&C Red 40).	Documentation & Change Control
2026-07-01	Class I	George J Howe Company, Inc.H-1120-2026	The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.	Documentation & Change Control
2026-07-01	Class II	Medtronic Perfusion SystemsZ-2576-2026	During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.	Documentation & Change Control
2026-07-01	Class II	Philips North America LlcZ-2523-2026	Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.	Documentation & Change Control
2026-07-01	Class II	Medline Industries, LPZ-2583-2026	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.	Documentation & Change Control
2026-06-24	Class III	Sandoz IncD-0608-2026	Labeling: Incorrect or Missing Lot and/or Exp Date	Documentation & Change Control
2026-06-24	Class II	Fairhope Roasting CompanyH-0951-2026	Product requires refrigeration but the label is missing a "Keep Refrigerated" statement	Documentation & Change Control
2026-06-24	Class II	Howmedica Osteonics Corp.Z-2461-2026	Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).	Documentation & Change Control
2026-06-24	Class II	Nutrisystem IncH-0947-2026	Undeclared Allergen (Soy)	Documentation & Change Control
2026-06-24	Class II	MID DOLCIARIA SRLH-0946-2026	The product contains unapproved colors chlorophyll E140 and E141.	Documentation & Change Control
2026-06-24	Class II	Dkiru LLCH-1079-2026	Undeclared melatonin.	Documentation & Change Control
2026-06-24	Class II	Ajanta Pharma USA IncD-0594-2026	Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.	Documentation & Change Control
2026-06-24	Class III	United Salt CorpH-0952-2026	Plain salt was labeled as iodized and iodized salt was labeled as plain.	Documentation & Change Control
2026-06-24	Class I	Azuma Foods International Inc USAH-1075-2026	Undeclared fish.	Documentation & Change Control

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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.