FDA Device recall Z-0514-2026
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P by Medline Industries, citing medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0514-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-30 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
Reason
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Identifiers
| code_info | 1) REF DYNJ00281P: UDI/DI 10195327411954 (each), 40195327411955 (case), Lot Numbers: 23GMD333, 23HMC426; 2) REF DYN…1) REF DYNJ00281P: UDI/DI 10195327411954 (each), 40195327411955 (case), Lot Numbers: 23GMD333, 23HMC426; 2) REF DYNJ68213C: UDI/DI 10195327511999 (each), 40195327511990 (case), Lot Numbers: 23IMI021, 23KMJ671. |
|---|
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-0514-2026%22
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