CLASS II ONGOING Device recall · Reported 25 Oct 2023 · FDA Enforcement Report

DeRoyal Head and Neck procedure kit recalled by DeRoyal Industries

DeRoyal Industries is recalling DeRoyal Head and Neck procedure kit, distributed in Pennsylvania. The recall was initiated on 18 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027

Quantity recalled32 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-0116-2024
FDA event ID: 93078
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Ongoing
Recall initiated: 18 Sep 2023
FDA classified: 16 Oct 2023
Reported: 25 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

18 Sep 2023	Recall initiated by company
16 Oct 2023	Classified by FDA	+28 days
25 Oct 2023	Published in enforcement report	+9 days

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

Reason for recall

DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

Where it was distributed

Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027

Where was it sold?

Pennsylvania

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.

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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