FDA Device recall Z-2789-2026
Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O by Medline Industries, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2789-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-11 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | CT, FL, KS, MA, MD, MT, NY, OH, OR, VA |
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.
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.
Identifiers
| code_info | Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239; Medline Kit SKU D…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2789-2026%22
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