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CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report

Geo-med Upper Extermity Pack recalled by DeRoyal Industries

DeRoyal Industries is recalling Geo-med Upper Extermity Pack, distributed in 23 states. The recall was initiated on 3 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: Lot 56189375 exp 10/1/2024; Lot 56392381 exp 10/1/2024; Lot 56618504 exp 11/1/2024; Lot 57392455 exp 2/1/2025; Lot 5775963 exp 4/1/2025

Quantity recalled243 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0605-2023
FDA event ID: 91134
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Ongoing
Recall initiated: 3 Nov 2022
FDA classified: 15 Dec 2022
Reported: 21 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

3 Nov 2022	Recall initiated by company
15 Dec 2022	Classified by FDA	+42 days
21 Dec 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

XXX

Product as listed by the FDA

GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02

Where it was distributed

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Alabama Arizona Connecticut Florida Georgia Illinois Indiana Kansas Louisiana Massachusetts Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York Ohio Pennsylvania Tennessee

Questions about this recall

Is Geo-med Upper Extermity Pack recalled?

Yes. DeRoyal Industries recalled Geo-med Upper Extermity Pack on 3 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0605-2023.

Why was it recalled?

XXX

Which lots are affected?

Lot Numbers: Lot 56189375 exp 10/1/2024; Lot 56392381 exp 10/1/2024; Lot 56618504 exp 11/1/2024; Lot 57392455 exp 2/1/2025; Lot 5775963 exp 4/1/2025

Where was it sold?

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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13 Nov 2024Device	CLASS II	DeRoyal C-section Tracepack recalled by DeRoyal Industries	DeRoyal Industries	Other	Nationwide
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