MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF D
Pending LLM rewrite. Source: FDA_DEVICE Z-0514-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
- SevereABIOMED Insertion Kit heart pump accessories introducer sheath leakage
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22