- 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)
- DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ69318A lots 23FMA845 23FMA924 25BMF603
- 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-1886-2026
- 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