Recall Z-3063-2026
Medline Industries, LP · initiated June 12, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTOMY KIT, Catalog Number: DYNDB3006C; 5) PLATELET PHLEBOTOMY KIT, Catalog Number: DYNDB3007C; 6) WHOLE BLOOD KIT, Catalog Number: DYNDB3041D; 7) PHLEBOTOMY, Catalog Number: DYNDB3044D; 8) PHLEBOTOMY, Catalog Number: DYNDB3044F; 9) DONATION - WB, Catalog Number: DYNDB3086D; 10) DONATION - ALYX/TRIMA W/O TOUR, Catalog Number: DYNDB3088B; 11) THERAPEUTIC NFT, Catalog Number: DYNDB3100; 12) BLOOD CULTURE TRAY ADULT, Catalog Number: DYNDH1194A; 13) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1444D; 14) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1445C; 15) BLOOD CULTURE KIT, Catalog Number: DYNDH1462B; 16) BLOOD CULTURE ADULT, Catalog Number: DYNDH1619A; 17) BLOOD CULTURE PEDI, Catalog Number: DYNDH1620A; 18) BLOOD CULTURE KIT, Catalog Number: DYNDH1622C; 19) BLOOD CULTURE KIT, Catalog Number: DYNDH1622D; 20) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1626B; 21) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1694A; 22) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1695; 23) BLOOD CULTURE KIT, Catalog Number: DYNDH1708A; 24) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1714A; 25) BLOOD CULTURE KIT, Catalog Number: DYNDH1715B; 26) BLOOD CULTURE KIT, Catalog Number: DYNDH1723; 27) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740A; 28) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740B; 29) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741A; 30) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741B; 31) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1771A; 32) BLOOD CULTURE KIT, Catalog Number: DYNDH1805B; 33) BLOOD CULTURE KIT, Catalog Number: DYNDH1817A; 34) BLOOD CULTR KT DIVRSN DEVICE, Catalog Number: DYNDH1866; 35) BLOOD CULTURE KIT, Catalog Number: DYNDH1867; 36) BLOOD CULTURE KIT, Catalog Number: DYNDH1884; 37) PHLEBOTOMY BLOOD CULTURE KIT, Catalog Number: DYNDH1908; 38) BLOOD CULTURE KIT, Catalog Number: DYNDH1912; 39) BLOOD CULTURE KIT, Catalog Number: DYNDH1940; 40) BLOOD CULTURE KIT W/O BOTTLES, Catalog Number: DYNDH1985; 41) BLOOD CULTURE KIT, Catalog Number: DYNDH1988; 42) BLOOD CULTURE, Catalog Number: DYNDH2002; 43) BLOOD CULTURE W/NO IV, Catalog Number: DYNDH2016; 44) BLOOD CULTURE W/IV, Catalog Number: DYNDH2017; 45) BLOOD CULTURE KIT, Catalog Number: DYNDH2023; 46) BLOOD CULTURE KIT, Catalog Number: DYNDH2028; 47) BLOOD CULTURE KIT, Catalog Number: DYNDH2030; 48) BLOOD CULTURE KIT, Catalog Number: DYNDH2048; 49) BLOOD CULTURE KIT, Catalog Number: DYNDH2059; 50) BLOOD CULTURE KIT 450, Catalog Number: DYNDH2074; 51) BLOOD CULTURE-NB, Catalog Number: DYNDH2089
Codes / lots: 1) DYLAB1081, UDI-DI: 10198459199608(each), 40198459199609(case), Lot Number: 25CMC514; 2) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 24CBG614; 3) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 24CBT912; 4) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23HBH298; 5) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23JBN521; 6) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23KBT270; 7) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25BBD241; 8) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25BBP477; 9) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25CBI161; 10) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24LBM458; 11) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24FBL961; 12) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24FBS200; 13) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24IBO183; 14) DYNDB3006C, UDI-DI:…
Reason for recall
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
FDA-determined cause: Nonconforming Material/Component
Action taken
An URGENT MEDICAL DEVICE RECALL notification letter dated 6/12/25 was sent to customers. 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. 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 form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 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 include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-3063-2026
- Initiated
- June 12, 2026
- Posted by FDA
- August 31, 2026
- Product code
- OIB – Blood And Urine Collection Kit (Excludes Hiv Testing)
- Quantity
- 996692 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3048-2026 Class II | Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2)…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3049-2026 Class II | Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3050-2026 Class II | Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3051-2026 Class II | Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3052-2026 Class II | Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437DThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3053-2026 Class II | Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375CThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3054-2026 Class II | Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3055-2026 Class II | Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3056-2026 Class II | Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3057-2026 Class II | Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3058-2026 Class II | Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3059-2026 Class II | Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3060-2026 Class II | Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702BThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3061-2026 Class II | Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number:…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |
| Z-3062-2026 Class II | Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | 06/12/2026Open, Classified |