Device recall
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: DYNDH1695; 7) DYNDH1708A, Catalog Number: DYNDH1708A; 8) DYNDH1714A, Catalog Number: DYNDH1714A; 9) DYNDH1723, Catalog Number: DYNDH1723; 10) DYNDH1740B, Catalog Number: DYNDH1740B; 11) DYNDH1741B, Catalog Number: DYNDH1741B; 12) DYNDH1771A, Catalog Number: DYNDH1771A; 13) DYNDH1908, Catalog Number: DYNDH1908; 14) DYNDH1940, Catalog Number: DYNDH1940; 15) DYNDH1988, Catalog Number: DYNDH1988; 16) DYNDH2002, Catalog Number: DYNDH2002; 17) DYNDH2017, Catalog Number: DYNDH2017. Blood and urine collection kits
- Recall number
- Z-3127-2026
- Event id
- 99669
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 23, 2026
- Posted
- Sep 14, 2026
- Initiated
- Aug 11, 2026
- Center classification date
- Sep 14, 2026
- Product code
- OIB
- Device type
- Blood And Urine Collection Kit (Excludes Hiv Testing)
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 47848 kits
- Code info
- 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, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24HBG622; 5) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24GBY827; 6) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBQ593; 7) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBU881; 8) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24EBI901; 9) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24HBG834; 10) DYNDH1695, UDI-DI: 10195327113155(each), 40195327113156(case), Lot Number: 24FBQ907; 11) DYNDH1708A, UDI-DI: 10195327498368(each), 40195327498369(case), Lot Number: 24IBQ580; 12) DYNDH1714A, UDI-DI: 10195327347550(each), 40195327347551(case), Lot Number: 24EBI892; 13) DYNDH1714A, UDI-DI: 10195327347550(each), 40195327347551(case), Lot Number: 24IBE380; 14) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24EBI893; 15) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24GBH135; 16) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24HBG826; 17) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24EBV834; 18) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24FBH710; 19) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24FBK197; 20) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24GBW340; 21) DYNDH1741B, UDI-DI: 10198459006319(each), 40198459006310(case), Lot Number: 24FBJ622; 22) DYNDH1741B, UDI-DI: 10198459006319(each), 40198459006310(case), Lot Number: 24GBW330; 23) DYNDH1771A, UDI-DI: 10198459088971(each), 40198459088972(case), Lot Number: 24IBJ998; 24) DYNDH1908, UDI-DI: 10195327472467(each), 40195327472468(case), Lot Number: 24EBC055; 25) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24FMH509; 26) DYNDH1988, UDI-DI: 10195327628772(each), 40195327628773(case), Lot Number: 24HBF080; 27) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24GBO301; 28) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24HBQ827; 29) DYNDH2017, UDI-DI: 10198459022159(each), 40198459022150(case), Lot Number: 24HBO219
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States