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MEDLINE INDUSTRIES, INC.

MEDLINE INDUSTRIES, INC. · Model DYNDA3216 · UDI-DI 10198459453687

OFR Prescription
0
510(k) clearances
22
Adverse events
7
Recalls
29
Facilities

Description

BRONCHOSCOPY PACK (BRVCA)222

Recalls

DateFirmReason
2026-07-10Medline Industries, LPComponent labeling discrepancy
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
2026-02-16Medline Industries, LPKits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves.
2025-12-24Medline Industries, LPA smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may
2024-10-09MEDLINE INDUSTRIES, LP - NorthfieldMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile

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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.