FDA Device recall Z-0522-2026
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R
- 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) BASIC NEURO PACK, REF CDS780202R 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-0522-2026 |
| 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) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
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 CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23LMG063; 2) REF CDS941061M, UDI…1) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23LMG063; 2) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 24ABG356, 24CBH117, 24DBJ347; 3) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23JMC956, 23KMF585, 24AMB974; 4) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 23EBS176, 23GBF899, 23HBZ085; 5) REF DYNJ44882M, UDI/DI 10195327382803 (each) 40195327382804 (case), Lot Numbers: 23FDA522, 23GDB903; 6) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers: 23IBD913, 23IBD914, 23JBL889, 24ABE596, 24BBL042, 24CBH196, 24DBU825. |
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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-0522-2026%22
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