[pending] MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR C
Pending LLM rewrite. Source: FDA_DEVICE Z-0521-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJO
- 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)
- REF 24BBC860: UDI/DI 10195327601492 (each)
- 40195327601493 (case)
- Lot Numbers: 24BBC860
- REF 24BBU607: UDI/DI 10193489848434 (each)
- 40193489848435 (case)
- Lot Numbers: 24BBU607
- REF 24CBU583: UDI/DI 10193489848434 (each)
- Lot Numbers: 24CBU583
- REF 24EBE546: UDI/DI 10193489848434 (each)
- Lot Numbers: 24EBE546
- REF 23GBF733: UDI/DI 10193489445442 (each)
- 40193489445443 (case)
- Lot Numbers: 23GBF733
- REF 24ABG140: UDI/DI 10193489445442 (each)
- Lot Numbers: 24ABG140
- REF 24BBN521: UDI/DI 10193489445442 (each)
- Lot Numbers: 24BBN521
- REF 24CBR696: UDI/DI 10193489445442 (each)
- Lot Numbers: 24CBR696
- REF 24EBK857: UDI/DI 10193489445442 (each)
Distribution
Distributed nationwide across the United States.
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