FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
- Recall number
- Z-0307-2025
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
- Status
- Open, Classified
- Initiated
- 2024-10-03
- Posted
- 2024-11-05
- Terminated
- not on file
- Reason
- 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.
- 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
- 160 units
- Distribution
- US Nationwide distribution in the state of OH.
- Lot, serial or model codes
- UDI/ DI 00749756916646 (each), 50749756916641 (case): Lot Numbers: lot 59839716 exp 12/1/2025
- 510(k) numbers
- ["K842648"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28