[pending] MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD,
Pending LLM rewrite. Source: FDA_DEVICE Z-0519-2026.
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) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #
- 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 CDS983639K: UDI/DI 10195327351533 (each)
- 40195327351534 (case)
- Lot Number 23FBP157
- Lot Number 23GBM569
- REF CDS984267J: UDI/DI 10193489288872 (each)
- 40193489288873 (case)
- Lot Number 23LBN523
- Lot Number 24BBA266
- Lot Number 24CBS676
- Lot Number 24EBM454
- REF DYNJ00264M: UDI/DI 10195327418717 (each)
- 40195327418718 (case)
- Lot Number 23HMA639
- Lot Number 23HMF507
- REF DYNJ0428947L: UDI/DI 10195327329136 (each)
- 40195327329137 (case)
- Lot Number 23GMI327
- Lot Number 23JMC006
- Lot Number 23LMA065
- Lot Number 23LMC367
Distribution
Distributed nationwide across the United States.
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