Recall Z-2789-2026
Medline Industries, LP · initiated June 11, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.
Codes / lots: Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743; Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487; Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802.
Reason for recall
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
FDA-determined cause: Process change control
Action taken
Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees via email and USPS first class mail. The notice explained the issue with the device, potential harms, and requested the following: REQUIRED ACTION: 1. Immediately check 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 the response form. Please list the quantity of affected product in inventory on the form. Even if there is no affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com 3. Upon receipt of the response form, the consignee account will receive over-labels to place on affected inventory, with instructions for the staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors and those who transferred the affected product were directed to notify those to which the product was distributed or transferred. For contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-2789-2026
- Initiated
- June 11, 2026
- Posted by FDA
- July 23, 2026
- Product code
- LRO – General Surgery Tray
- Quantity
- 398 kits
- Distribution
- US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2788-2026 Class II | Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline…Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | 06/11/2026Open, Classified |
| Z-2790-2026 Class II | Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397PMedline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | 06/11/2026Open, Classified |
| Z-2791-2026 Class II | Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU…Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | 06/11/2026Open, Classified |