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Medline Industries, Inc.

MEDLINE INDUSTRIES, INC. · Model DYNJ57154F · UDI-DI 10195327201982

FDE Prescription
4
510(k) clearances
256
Adverse events (2 deaths)
120
Recalls
43
Facilities

Description

ROBOTIC PACK

Recalls

DateFirmReason
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
2026-06-12Medline Industries, LPThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-03-19Medline Industries, LPDuring 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-o
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2026-02-27Medline Industries, LPFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
2026-02-27Medline Industries, LPUnapproved design changes to the products outside of the 510(k) clearance.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-01-07Medline Industries, LPMedline 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 packag

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.