Z-2789-2026Class II

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK...

Name: Z-2789-2026 Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK...
Creator: Medline Industries, LP
Published: 2026-06-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-06-11 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT... on 2026-06-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2789-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-11
Posted: 2026-07-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: LRO General Surgery Tray
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 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 [email protected].
Quantity in commerce: 398 kits
Distribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2789-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2788-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2789-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2790-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23
Z-2791-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)