FDAFDA · Food and drugs·Recall number Z-0642-2025
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
Published December 11, 2024 · Recall initiated: October 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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