Z-0642-2025 Class II Ongoing
FDA device recall Z-0642-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Oct 9, 2024 and is designated Class II. Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. The recall status is ongoing. Affected quantity: 336 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 11, 2024
- Initiation Date
- Oct 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 336 units
Product Description
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution Pattern
US Nationwide distribution.
Code Information
1) REF DYNJ0531985R, UDI/DI 10195327216405 (each) 40195327216406 (case), Lot Numbers: 22HMF853, 23CMA603, 22LMG691; 2) REF DYNJ0843760I, UDI/DI 10195327365141 (each) 40195327365142 (case), Lot Numbers: 23DDA645; 3) REF DYNJ0843760J, UDI/DI 10195327491369 (each) 40195327491360 (case), Lot Numbers: 23JDA821
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0642-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026