Something drifted in the manufacturing process that quality controls did not catch in time. The FDA lists 348 recalls with this root cause since 2025, 25 of them Class I (most serious). Most recent report: Oct 7, 2026.
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or…
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the pl…
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or…
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or…
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Gowns do not consistently meet the minimum liquid-barrier performance required.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.