FDA Medical Device Recalls (openFDA)
Medline Industries, LP: 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.
- Recall number
- Z-2789-2026
- Recalling firm
- Medline Industries, LP
- 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.
- Status
- Open, Classified
- Initiated
- 2026-06-11
- Posted
- 2026-07-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 398 kits
- Distribution
- US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28