Z-1847-2026 Class II Ongoing
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
- 89 units
Product Description
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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) DYNJ48399C, UDI-DI: 10195327172626(each), 40195327172627(case), Lot Number: 24CBU779; 2) DYNJ62849B, UDI-DI: 10195327514884(each), 40195327514885(case), Lot Number: 24BBS275