Reported May 13, 2026 · Ongoing
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number:…
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) DRAPE PACK
- Model Number
DYNJ35363A2) SICK KIDS-GENERAL CUSTOM SPLIT
- Model NumberSPTPCD10005
- Lot codes and dates
- 1) DYNJ35363A
- UDI-DI
10884389516461(each)40884389516462(case)
- Lot Number
21BBP0202) SPTPCD10005
- UDI-DI
10080196228652(each)40080196228653(case)
- Lot Number24JBB041
- Amount recalled
- 240 units
This recall covers 42 products
The agency filed one notice per product. You are reading one of them; the other 41 are below.
29 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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