Z-1886-2026 Class II Ongoing
FDA device recall Z-1886-2026 was initiated by Medline Industries, LP on February 27, 2026 and is designated Class II. Reason for recall: Unapproved design changes to the products outside of the 510(k) clearance. The recall status is ongoing. Affected quantity: 270,311 total.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- February 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270,311 total
Product Description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
Reason for Recall
Unapproved design changes to the products outside of the 510(k) clearance.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Code Information
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