FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691
- Recall number
- Z-0627-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691
- 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
- 980 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 1) REF DYNJ0160598C, UDI/DI 10195327304270 (each) 40195327304271 (case), Lot Numbers: 23ADA376, 23DDA345, 23ADB824; 2) REF DYNJ0842590G, UDI/DI 10195327286439 (each) 40195327286430 (case), Lot Numbers: 23HDA481, 23DDB914, 23DDA319; 3) REF DYNJ41473G, UDI/DI 10193489983982 (each) 40193489983983 (case), Lot Numbers: 22KMD254, 23KBD038, 23EMK120, 23CMA828; 4) REF DYNJ41473I, UDI/DI 10195327584931 (each) 40195327584932 (case), Lot Numbers: 24DBF911; 5) REF DYNJ44148G, UDI/DI 10195327412487 (each) 40195327412488 (case), Lot Numbers: 23EBV384, 23JBW504, 23KBG481; 6) REF DYNJ81776A, UDI/DI 10195327515881 (each) 40195327515882 (case), Lot Numbers: 23LBN724, 24CBH515; 7) REF DYNJ82691, UDI/DI 10195327202934 (each) 40195327202935 (case), Lot Numbers: 23GMI494, 23JMH927
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFG
- 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