Z-0306-2025Class II

DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

Name: Z-0306-2025 DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Creator: DeRoyal Industries Inc
Published: 2024-10-03
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2024-10-03 / Open, Classified

FDA source

DeRoyal Industries Inc began a recall of DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 on 2024-10-03. FDA classified it as Class II and gives the reason as "DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0306-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-03
Posted: 2024-11-05
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
FDA root cause: Under Investigation by firm
Action: DeRoyal issued an URGENT! DEROYAL RECALL NOTICE to its consignees on 10/03/2024 via email. The notice explained the issue, potential risk, and requested the return of the affected packs. If the affected product was further distributed, the notice directed the distributor to notify its customers. This may be achieved directly by forwarding the recall notification and notify DeRoyal that you have done so, or the distributor may provide DeRoyal with your customer listing allowing them to contact your customers.
Quantity in commerce: 780 units
Distribution: US Nationwide distribution in the state of OH.
Product codes and lots: UDI/ DI 00749756927864 (each), 50749756927869 (case): Lot Numbers: 59098305, exp 4/1/2027; 59161271, exp 3/1/2025; 59245221, exp 6/1/2025; 59287659, exp 5/1/2025; 59716337, exp 5/1/2025;59866546, exp 12/1/2025; 59962811, exp 11/1/2025; 59996754, exp 12/1/2025; 60104426, exp 11/1/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0306-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0306-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-05
Z-0307-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-05
Z-0308-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-05
Z-0309-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-05

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)