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RecallWatchMedical Device Safety
Class IIOngoingZ-1880-2026

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

Medline Industries, LPNorthfield, IL, United StatesReported Apr 29, 2026 · 2 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI
10193489352351 (EA) 40193489352352 (CS) LOTS 22CDB133 22EDA975 22FDA831 22HDC403 DYNJ0101278G
UDI
10195327286477 (EA) 40195327286478 (CS) LOTS 22KDB109 22LDA476 23CDA805 23DDB546 23EDC278 23FDC023 23JDA625 23KDB893 24ADB642 24BDB842 24CDB908 24GDA043 24IDA026…Show all
10195327286477 (EA) 40195327286478 (CS) LOTS 22KDB109 22LDA476 23CDA805 23DDB546 23EDC278 23FDC023 23JDA625 23KDB893 24ADB642 24BDB842 24CDB908 24GDA043 24IDA026 DYNJ0101278I
UDI
10198459119477 (EA) 40198459119478 (CS)
Lot #
24JDC169 DYNJ56262
UDI
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 21JDB2…Show all
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

What the firm is doing

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.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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