Device recall
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
- Recall number
- Z-3022-2026
- Event id
- 99507
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 2, 2026
- Posted
- Aug 26, 2026
- Initiated
- Jul 10, 2026
- Center classification date
- Aug 26, 2026
- Product code
- FDE
- Device type
- Laparoscopy Kit
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
- Root cause
- Process change control
- Quantity
- 94 kits
- Code info
- Medline Kit SKU CDS982040U, UDI/DI 10198459385421 (each) 40198459385422 (case), Lot Number 26AMC355; Medline Kit SKU DYNJ89608, UDI/DI 10198459279324 (each) 40198459279325 (case), Lot Number 25JBR465; Medline Kit SKU DYNJ903479L, UDI/DI 10198459255250 (each) 40198459255251 (case), Lot Number 25LMB480; Medline Kit SKU DYNJ903479M, UDI/DI 10198459790591 (each) 40198459790592 (case), Lot Number 26FMB173.
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States