Z-1882-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- February 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270,311 total
Product Description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Reason for Recall
Unapproved design changes to the products outside of the 510(k) clearance.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Code Information
DYNJ80343C UDI-DI 10195327507299 (EA) 40195327507290 (CS) LOT 24ABO127 DYNJ86639 UDI-DI 10195327661922 (EA) 40195327661923 (CS) LOT 24FBM972