Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes

Recalling company

Medline Industries, LP

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 27, 2026

Reported

Apr 29, 2026

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Status

Ongoing

Quantity

270,311 total

Lot / codes

DYNJ0101278F UDI-DI 10193489352351 (EA) 40193489352352 (CS) LOTS 22CDB133 22EDA975 22FDA831 22HDC403 DYNJ0101278G UDI-DI 10195327286477 (EA) 40195327286478 (CS) LOTS 22KDB109 22LDA476 23CDA805 23DDB546 23EDC278 23FDC023 23JDA625 23KDB893 24ADB642 24BDB842 24CDB908 24GDA043 24IDA026 DYNJ0101278I UDI-DI 10198459119477 (EA) 40198459119478 (CS) LOT 24JDC169 DYNJ56262 UDI-DI 10889942624331 (EA) 40889942624332 (CS) LOT 24ABO125 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ0101278F lots 21ADC024 21CDA355 21EDA527 21GDC529 21IDA040 21IDA786 21JDB214 21KDC443 22ADC117 22GDA789; DYNJ0101278G lots 23HDC100; DYNJ0101278I lots 25AME306 25AMI354 25BMG147 25BMG147A

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-1880-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1880-2026 in the FDA Enforcement Report. Also see FDA recall press releases.