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Medline Band Bags and Equipment Covers

by Medline Industries, Inc.

510(k) K032065

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032065 Date22 Sep 2003ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2154-2023 FDA Class II initiated 18 May 2023

    Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

    • Ongoing Z-2290-2023 FDA Class II initiated 15 May 2023

    Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MMP
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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