Reported Sep 9, 2026 · Ongoing · Updated Sep 16, 2026
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline Convenience Kits1) ULTRASOUND BREAST PACK
- Model NumberDYNJ63375C
- Lot codes and dates
- 1) DYNJ63375C
- UDI-DI
10193489851823(each)40193489851824(case)
- Lot Number23LMC035
- Amount recalled
- 300 kits
This recall covers 29 products
The agency filed one notice per product. You are reading one of them; the other 28 are below.
16 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
This product could cause temporary or reversible health problems — stop using it.
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