- Recalling firm
- Medline Industries, LP
- Reason for recall
- Unapproved design changes to the products outside of the 510(k) clearance.
- Affected products (lot / model / serial)
- DYNJ34846C UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT 24BBA459 DYNJ83218A UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT 24BBD199 DYNJ85396 UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT 24BBA503 DYNJ905156R UDI-DI 10198459017704 (EA) 40198459017705 (CS) LOTS 24HBG726 24JBJ484 25ABS758 25BBR196 25CBN174 25EBE136 DYNJ905159L UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT 24EMB726 DYNJ905159M UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT 24GMA714 24HMD401 24HMJ945 24JMD201 24KMG592 25AMC024 25BMD945 25CMG373 DYNJ69926A UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT 24ABS445 DYNJ41250B UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT 24ABO122 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767
- Units affected
- 270,311 total
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1887-2026
- Recall initiated
- February 27, 2026
- FDA classification date
- April 17, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98601
- Last updated on HTM Vibe
- July 24, 2026