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Medline Industries, Inc. DYNJAA0087A

by Medline Industries, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889942280063 UDI-DI Date29 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0449-2026 FDA Class I initiated 10 Oct 2025

    Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

    • Ongoing Z-3031-2024 FDA Class II initiated 8 Apr 2024

    Medical 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 may pose a risk to patient health.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Medline Industries, Inc.
Generic Name
General surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
DYNJAA0087A
Primary DI / UDI-DI
10889942280063
FDA Product Code
CAH
GMDN Term
General surgical procedure kit, non-medicated, reusable
Device Class
Class II
Regulation Number
868.5260
GUDID distribution status
In Commercial Distribution

Related devices

Category: General surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K925217)

Show all (12)

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No