Device recall
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
- Recall number
- Z-3026-2026
- 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
- OHM
- Device type
- Cesarean Section Tray
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
- Root cause
- Process change control
- Quantity
- 106 kits
- Code info
- Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26DMG417; Medline Kit SKU DYNJ911755, UDI/DI 10198459523946 (each) 40198459523947 (case), Lot Number 25KMI628; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABJ549; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABI899; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 25LBT433.
- 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