Device recall
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L.
- Recall number
- Z-3027-2026
- 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
- OJF
- Device type
- Hysterectomy Kit
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
- Root cause
- Process change control
- Quantity
- 169 kits
- Code info
- Medline Kit SKU CDS982273U, UDI/DI 10198459385827 (each) 40198459385828 (case), Lot Number 25LBR956; Medline Kit SKU CDS982273U, UDI/DI 10198459385827 (each) 40198459385828 (case), Lot Number 25KBP729; Medline Kit SKU CDS982654L, UDI/DI 10195327306830 (each) 40195327306831 (case), Lot Number 26EBN087; Medline Kit SKU CDS982662Q, UDI/DI 10195327306793 (each) 40195327306794 (case), Lot Number 25JBK543; Medline Kit SKU DYNJ54382F, UDI/DI 10198459794285 (each) 40198459794286 (case), Lot Number 26FMC227; Medline Kit SKU DYNJ903467L, UDI/DI 10198459293207 (each) 40198459293208 (case), Lot Number 26DMK551; Medline Kit SKU DYNJ903467L, UDI/DI 10198459293207 (each) 40198459293208 (case), Lot Number 26DMB880.
- 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