Agency classClass IIOur severity:Severe FDA (Devices)·Z-3060-2026·Announced 2026-09-09

Medline C-Section Prep Kits Recalled for Potential Sterility Breach

Medline is recalling 352 C-Section Prep kits due to packaging defects 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that potential health consequences include hospitalization and that severe infection could become life-threatening, which aligns with the rubric criteria for a Severe (Score 4) classification involving significant injury or hospitalization reports.

Plain-English summary

Medline Industries, LP is recalling 352 units of C-Section Prep Convenience Kits (Model Number DYNJ32702B) distributed nationwide in the United States. The recall involves specific lots identified by UDI-DI 10193489431070 and 40193489431071, with lot numbers 25BBG443, 25EBL829, 24EBR761, 24GBC622, 24GBX458, and 23LBT973.

The recall is due to a potential breach of sterility in the packaging of the BD ChloraPrep Clear and FREPP Clear applicators included in the kits. Wrinkles in the paper lidding may extend to the seal area, potentially compromising the sterile barrier. If the barrier is compromised, patients and users may be exposed to microbial contamination.

Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, or hospitalization. In rare cases, severe infection could become life-threatening, particularly for critically ill or immunocompromised patients. Consumers and healthcare providers should check their inventory for the affected model and lot numbers and stop using these kits if they match the recalled description.

The recalled product

Product: Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
Manufacturer: Medline Industries, LP
Category: Medical Device — Surgical Prep Kits
Hazard: microbial-contamination
infection
sterility-breach
Affected units: 352

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 (14)

1) DYNJ32702B
UDI-DI: 10193489431070(each)
40193489431071(case)
Lot Number: 25BBG443
2) DYNJ32702B
Lot Number: 25EBL829
3) DYNJ32702B
Lot Number: 24EBR761
4) DYNJ32702B
Lot Number: 24GBC622
5) DYNJ32702B
Lot Number: 24GBX458
6) DYNJ32702B
Lot Number: 23LBT973

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medline Industries, LP

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Same hazard · microbial contamination