Recall Z-3127-2026
Medline Industries, LP · initiated August 11, 2026
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: 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
Codes / lots: 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:…
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
An URGENT MEDICAL DEVICE RECALL notification letter dated 8/11/26 was sent to customers. This communication serves as an update to the Medline notification sent on June 12, 2026. Please be advised that the actions required for certain item(s) and lot(s) identified in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company). REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX3 Recall Code: 3.Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-3127-2026
- Initiated
- August 11, 2026
- Posted by FDA
- September 14, 2026
- Product code
- OIB – Blood And Urine Collection Kit (Excludes Hiv Testing)
- Quantity
- 47848 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3121-2026 | Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199AThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | 08/11/2026Open, Classified |
| Z-3122-2026 | Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | 08/11/2026Open, Classified |
| Z-3123-2026 | Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2)…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | 08/11/2026Open, Classified |
| Z-3124-2026 | Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | 08/11/2026Open, Classified |
| Z-3125-2026 | Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | 08/11/2026Open, Classified |
| Z-3126-2026 | Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | 08/11/2026Open, Classified |