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Medline Industries, Inc.

MEDLINE INDUSTRIES, INC. · Model DYKMBNDL9A · UDI-DI 10193489952001

OGR Prescription
0
510(k) clearances
80
Adverse events
73
Recalls
34
Facilities

Description

KIT ENT ROBOTIC

Recalls

DateFirmReason
2026-07-14Cardinal Health 200, LLCCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability o
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
2026-07-08Medline Industries, LPSpecific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev
2026-06-08Windstone Medical Packaging, Inc.The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C
2026-05-21Windstone Medical Packaging, Inc.Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization
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.
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
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, LPUnapproved design changes to the products outside of the 510(k) clearance.

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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.