FDAFDA recall Z-3122-2026 · Sep 23, 2026
Medline Industries, LP: Medline Convenience Kits: 1) OPEN HEART ADULT recall
Recall found
Product
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- 1) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 2) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24FBM444; 3) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24HBJ581; 4) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24HBT102
- Quantity
- 489 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-11
Source: openFDA enforcement record Z-3122-2026 · search recall number Z-3122-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.