FDA Device recall Z-0632-2025
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
- 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: PORT INSERTION PACK, REF DYNJ81597 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-0632-2025 |
| 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: PORT INSERTION PACK, REF DYNJ81597
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 DYNJ81597, UDI/DI 10195327124007 (each) 40195327124008 (case), Lot Numbers: 22IBF254, 23BBO299 |
|---|
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-0632-2025%22
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