Z-0631-2025 Class II Ongoing
FDA device recall Z-0631-2025 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: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 11, 2024
- Initiation Date
- Oct 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
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 DYNJ44673G, UDI/DI 10195327127473 (each) 40195327127474 (case), Lot Numbers: 23GDB181; 2) REF DYNJ49672L , UDI/DI 10195327127794 (each) 40195327127795 (case), Lot Numbers: 22GDB352, 22FDC210
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0631-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026