Medline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
Medline is recalling 47,848 blood and urine collection kits nationwide because they may contain Aspergillus penicillioides, a fungus that can cause serious infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the contamination may lead to death, which triggers the Critical severity score (5) per the rubric criteria for known fatalities or death reports.
Plain-English summary
Medline Industries, LP is recalling 47,848 blood and urine collection kits distributed nationwide. The recall involves 17 specific catalog numbers of Medline Convenience Kits. The affected products are sterile applicators that may contain fungal contamination.
The FDA identified that certain lots of these sterile applicators may contain Aspergillus penicillioides, a fungus that can grow under specific environmental conditions. Contamination of skin preparation products with this organism may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Consumers and healthcare facilities should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to Medline or the distributor for credit or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number…
- Manufacturer
- Medline Industries, LP
- Affected units
- 47,848
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYNDB3086D
- UDI-DI: 10195327313234(each)
- 40195327313235(case)
- Lot Number: 24IBA685
- 2) DYNDB3100
- UDI-DI: 10198459028915(each)
- 40198459028916(case)
- Lot Number: 24IBF913
- 3) DYNDH1619A
- UDI-DI: 10195327215835(each)
- 40195327215836(case)
- Lot Number: 24FBH708
- 4) DYNDH1619A
- Lot Number: 24HBG622
- 5) DYNDH1620A
- UDI-DI: 10195327216047(each)
- 40195327216048(case)
- Lot Number: 24GBY827
- 6) DYNDH1620A
- Lot Number: 24HBQ593
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline Tubal Ligation Kits Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
- ModerateMedline C-Section Drapes Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
- ModerateMedline C-Section Tray Kits Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
- ModerateMedline Medical Convenience Kits Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
- ModerateMedline C-Section Drapes Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
Same hazard · fungal contamination
See all →- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereMedline Anesthesia Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
Similar recalls
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- SevereMedline Anesthesia Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- SevereMedline Blood Culture Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09