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Recover Infant Heel Warmer (5100)

by Florida Medical Industries, Inc.

510(k) K964523

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK964523 Date10 Feb 1997ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2094-2021 FDA Class II initiated 9 Jun 2021
    • Terminated Z-2095-2021 FDA Class II initiated 9 Jun 2021

    A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.

  • 2 recalls, same reason

    • Terminated Z-2443-2015 FDA Class II initiated 31 Jul 2015
    • Terminated Z-2444-2015 FDA Class II initiated 31 Jul 2015

    Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations

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  • Withdrawn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
MPO
Device Class
Class I
Regulation
21 CFR Part 890.5710
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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