MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPA
Pending LLM rewrite. Source: FDA_DEVICE Z-0524-2026.
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) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
- 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 CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case)
- Lot Numbers: 23LBV707
- Lot Numbers: 24CBD429
- Lot Numbers: 24CBD498
- Lot Numbers: 24DBK836
- Lot Numbers: 24HBE577
- REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case)
- Lot Numbers: 23HBO463
- Lot Numbers: 23JBF467
- REF CDS984262N: UDI/DI 10195327241735 (each) 40195327241736 (case)
- Lot Numbers: 24ABP835
- REF CDS984262P: UDI/DI 10195327647704 (each) 40195327647705 (case)
- Lot Numbers: 24CBK422
- REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case)
- Lot Numbers: 23GBT512
- Lot Numbers: 23HBI619
- Lot Numbers: 23LBN095
- Lot Numbers: 24BBR322
- Lot Numbers: 24DBA027
- Lot Numbers: 24DBT103
Distribution
Distributed nationwide across the United States.
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