Agency classClass IIOur severity:High FDA (Devices)·Z-3049-2026·Announced 2026-09-09

Medline Convenience Kits Recalled for Potential Sterility Breach

Medline is recalling 4,636 convenience kits nationwide due to packaging wrinkles that may compromise sterility, posing a risk of microbial contamination.

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: The FDA classified this as a Class II recall. The hazard involves a risk of harm (microbial contamination and infection) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Medline Industries, LP is recalling 4,636 convenience kits distributed nationwide. The recall involves specific catalog numbers including CDS840396X, CDS840396Y, CDS983348AA, CDS983348AB, CDS983672O, CDS983672P, DYKM1982, DYNDA1080, DYNJ67490C, DYNJ907400D, and DYNJ908990A. The kits contain BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators.

The recall is due to a potential breach of sterility in the packaging. Wrinkles in the paper lidding may extend to the seal area, which could compromise the sterile barrier. If the barrier is compromised, patients and users may be exposed to microbial contamination.

Potential health consequences include no injury, localized infection, or more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. The FDA has classified this as a Class II recall.

The recalled product

Product: Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog…
Manufacturer: Medline Industries, LP
Category: Medical Device — Surgical Kits
Hazard: microbial-contamination
infection
Affected units: 4,636

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 (20)

1) CDS840396X
UDI-DI: 10193489461916(each)
40193489461917(case)
Lot Number: 24ABC933
2) CDS840396X
Lot Number: 24ABK089
3) CDS840396X
Lot Number: 24ABL893
4) CDS840396Y
UDI-DI: 10195327574932(each)
40195327574933(case)
Lot Number: 25BBG163
5) CDS840396Y
Lot Number: 24KBK977
6) CDS840396Y
Lot Number: 24BBO585
7) CDS840396Y
Lot Number: 24CBR417
8) CDS840396Y
Lot Number: 24FBS930

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medline Industries, LP

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Same hazard · microbial contamination