CLASS II ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report

Sterile custom surgical procedure packs recalled by DeRoyal Industries

DeRoyal Industries is recalling Sterile custom surgical procedure packs 89-10529.04, Cnrv OR C-section Pack, New River, distributed nationwide in the US. The recall was initiated on 17 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(1) 89-10529.04 - lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339; (2) 89-10567.05 - lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305.

Quantity recalled23 cases (52 packs)

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-1692-2023
FDA event ID: 92299
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Ongoing
Recall initiated: 17 Apr 2023
FDA classified: 7 Jun 2023
Reported: 14 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

17 Apr 2023	Recall initiated by company
7 Jun 2023	Classified by FDA	+51 days
14 Jun 2023	Published in enforcement report	+7 days

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

Reason for recall

The custom procedure packs contain light handle covers that have been recalled by another firm.

Product as listed by the FDA

Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.

Where it was distributed

US Nationwide distribution in the state of VA.

Nationwide Virginia

Questions about this recall

Why was it recalled?

The custom procedure packs contain light handle covers that have been recalled by another firm.

Which lots are affected?

(1) 89-10529.04 - lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339; (2) 89-10567.05 - lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305.

Where was it sold?

US Nationwide distribution in the state of VA.

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

Other products in this recall event

1 other product · FDA event 92299

Reported	Class	Recall	Company	Reason	Where
14 Jun 2023	CLASS II	Sterile custom surgical procedure packs recalled by DeRoyal Industries	DeRoyal Industries	Foreign Material	Nationwide

More recalls from DeRoyal Industries

All 227

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recalled	DeRoyal Industries	Temperature Abuse	Nationwide
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

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