MEDLINE Convenience Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
1) REF DYNJ85691, UDI/DI 10195327534141 (each) 40195327534142 (case), Lot Numbers: 24ABR853, 2) REF DYNJ902123J, UDI/DI 10195327497453 (each) 40195327497454 (case), Lot Numbers: 23JDB498, 24DDA877, 24CDB678, 24BDB737
Products Sold
1) REF DYNJ85691, UDI/DI 10195327534141 (each) 40195327534142 (case), Lot Numbers: 24ABR853; 2) REF DYNJ902123J, UDI/DI 10195327497453 (each) 40195327497454 (case), Lot Numbers: 23JDB498, 24DDA877, 24CDB678, 24BDB737
MEDLINE INDUSTRIES, LP Northfield is recalling MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ90212 due to Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026