Medline Convenience Kits: 1) OPEN HEART ADULT recall (Medline Industries, LP)
Medical deviceClass IOngoing
Summary: Medline Industries, LP is recalling 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: 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 is being recalled
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
Why
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.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3122-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | August 11, 2026 |
| Reported | September 23, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 489 kits |
More recalls from Medline Industries, LP · all medical device recalls · recalls from August 2026