Recall Z-3028-2026

Medline Industries, LP · initiated July 10, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.

Codes / lots: Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 26BBA665; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25KBR602; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25JBH531; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25KBL876; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25JBS218.

Reason for recall

Kits contain a potentially contaminated component which were recalled by the manufacturer

FDA-determined cause: Process change control

Action taken

Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email. The notice explained the issue, potential hazard, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-120-FG-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Details

Recall number
Z-3028-2026
Initiated
July 10, 2026
Posted by FDA
August 26, 2026
Product code
OKV – Obstetrical Kit
Quantity
419 kits
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.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3019-2026 Class IIMedline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3020-2026 Class IIMedline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3021-2026 Class IIMedline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991SKits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3022-2026 Class IIMedline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3023-2026 Class IIMedline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MKits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3024-2026 Class IIMedline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3025-2026 Class IIMedline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3026-2026 Class IIMedline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3027-2026 Class IIMedline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified
Z-3029-2026 Class IIMedline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON…Kits contain a potentially contaminated component which were recalled by the manufacturer 07/10/2026Open, Classified