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

DeRoyal Biopsy Pack recalled by DeRoyal Industries

DeRoyal Industries is recalling DeRoyal Biopsy 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 56094211 exp 5/1/2024

Quantity recalled560 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-0643-2023
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: Other Medical Devices

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

DeRoyal BIOPSY PACK, REF 89-9270.04

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 DeRoyal Biopsy Pack recalled?

Yes. DeRoyal Industries recalled DeRoyal Biopsy Pack on 3 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0643-2023.

Why was it recalled?

XXX

Which lots are affected?

Lot Numbers: Lot 56094211 exp 5/1/2024

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.

More recalls from DeRoyal Industries

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled	DeRoyal Industries	Sterility	Nationwide
12 Mar 2025Device	CLASS II	DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled	DeRoyal Industries	Foreign Material	5 states
26 Feb 2025Device	CLASS II	DeRoyal AMG Suction Connector Tubing recalled by DeRoyal Industries	DeRoyal Industries	Packaging Defects	21 states
13 Nov 2024Device	CLASS II	DeRoyal C-section Tracepack recalled by DeRoyal Industries	DeRoyal Industries	Other	Nationwide
13 Nov 2024Device	CLASS II	DeRoyal Children's General Tracepack recalled by DeRoyal Industries	DeRoyal Industries	Other	Nationwide

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