Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Summary
The FDA issued a Class I for Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DY by Medline Industries, LP. Reason: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, all.
Details
Source
Device Recall
External ID
Z-3121-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Lot/Code Info: 1) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBH109; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBM182; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBS365
Quantity Affected: 12 kits
Reason for Recall
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-11
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3121-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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