Recall Z-1888-2026

Medline Industries, LP · initiated February 27, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D

Codes / lots: DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811

Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

FDA-determined cause: Component change control

Action taken

On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.

Details

Recall number
Z-1888-2026
Initiated
February 27, 2026
Posted by FDA
April 17, 2026
Product code
OII – Arthrogram Tray
Quantity
270,311 total
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1876-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1877-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1878-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1879-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1880-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1881-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1882-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1883-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1884-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1885-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1886-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1887-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1889-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1890-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1891-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1892-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified