FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
- Recall number
- Z-0637-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
- Status
- Open, Classified
- Initiated
- 2024-10-09
- Posted
- 2024-12-05
- Terminated
- not on file
- Reason
- Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Root cause
- Under Investigation by firm
- Action
- Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.
- Quantity
- 486 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 1) REF CDS983465N, UDI/DI 10195327497309 (each) 40195327497300 (case), Lot Numbers: 24CDB460, 24BDA880, 23KDB948; 2)REF CDS983465N, UDI/DI 10195327699987 (each) 40195327699988 (case), Lot Numbers: 24EDB092, 24EDA519; 3) REF DYNJ63331D, UDI/DI UDI/DI 10195327270346 (each) 40195327270347 (case), Lot Numbers: 23LME440, 23HMI168, 23KMD370
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJJ
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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