Z-1846-2026 Class II Ongoing
FDA device recall Z-1846-2026 was initiated by Medline Industries, LP on February 25, 2026 and is designated Class II. Reason for recall: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- February 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
Reason for Recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Distribution Pattern
US Nationwide distribution.
Code Information
1) DYNJ41257F, UDI-DI: 10193489708523(each), 40193489708524(case), Lot Number: 25GBL423