FDA Device recall Z-0636-2025
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0636-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Reason
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Identifiers
| code_info | REF DYNJ52141B, UDI/DI 10195327028459 (each) 40195327028450 (case), Lot Numbers: 23FMA347, 23JBS200 |
|---|
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-0636-2025%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.