MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CD
Pending LLM rewrite. Source: FDA_DEVICE Z-0516-2026.
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) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PAC
- 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 (20)
- 1) REF CDS984259O: UDI/DI 10195327297817 (each)
- 40195327297818 (case)
- Lot Numbers: 23FBR754
- 23GBH766
- 24ABP608
- 24BBN514
- 2) REF CDS984259P: UDI/DI 10195327647827 (each)
- 40195327647828 (case)
- Lot Numbers: 24DBQ755
- 3) REF DYNJ0160700F: UDI/DI 10195327304294 (each)
- 40195327304295 (case)
- Lot Numbers: 23FDA156
- 23GDA649
- 4) REF DYNJ0161710I: UDI/DI 10195327375003 (each)
- 40195327375004 (case)
- Lot Numbers: 23EDB639
- 23FDA196
- 23GDA674
- 5) REF DYNJ0161795F: UDI/DI 10195327375010 (each)
- 40195327375011 (case)
Distribution
Distributed nationwide across the United States.
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