RecallRadar

FDA Device recall Z-0622-2025

MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691

On 2024-12-11 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691 by Medline Industries Northfield, citing medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0622-2025
ClassificationClass II
Statusongoing
Initiated2024-10-09
Published2024-12-11
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J

Reason

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Identifiers

code_info
1) REF DYNJ85691, UDI/DI 10195327534141 (each) 40195327534142 (case), Lot Numbers: 24ABR853; 2) REF DYNJ902123J, UDI…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0622-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.