Agency classClass IIOur severity:High FDA (Devices)·Z-1599-2025·Announced 2025-04-23

Medline Convenience Kits Recalled for Potential Weak Seals

Medline Industries is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The affected kits are distributed nationwide and in Canada, Mexico, Panama, and the Virgin Islands.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving sterile medical device kits with potential packaging seal failures that could compromise sterility. While no reported illnesses or injuries are stated in the source, the risk-of-harm scenario—compromised sterile packaging on devices used for procedures—justifies a High severity rating per the rubric.

Plain-English summary

Medline Industries, LP is recalling select sterile convenience kits because of a potential for open or weak seals on the purchased breather pouches used for packaging. The recalled products include the T&A ENDO PACK (Model DYNJ59620A, Lot 24KBH321) and the TRAY ADD A CATH FOL UM MF 10ML (Model DYND150200S, Lot 24KBK308). A total of 530 units have been distributed.

The kits have been distributed nationwide in the United States and internationally to Canada, Mexico, Panama, and the Virgin Islands. Healthcare facilities and providers who have received these products should verify the integrity of the breather pouches before use. Patients or healthcare professionals who have concerns about these products should contact Medline Industries.

The recalled product

Product: Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Sterile Convenience Kits
Hazard: weak-seal
sterility-compromise
Affected units: 530

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

1) DYNJ59620A
UDI-DI: 10193489685367(each)
40193489685368(case)
Lot Number: 24KBH321
2) DYND150200S
UDI-DI: 10195327387884(each)
40195327387885(case)
Lot Number: 24KBK308

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 34 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · weak seal