The FDA has posted 35 enforcement recalls of orthopedic tray devices since 2025, including 7 Class I (most serious) recalls. Most recent report: Jul 1, 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.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter c…
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and repor…
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and repor…
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles;…
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Unapproved design changes to the products outside of the 510(k) clearance.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Orthopedic Tray”). Informational only — verify against the FDA before acting.