FDA Medical devices recall ·
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A recall
- Recall number
- Z-3062-2026
- Date
- (initiated June 12, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18290 kits
- Hazard tags
- Sterility Microbial contamination Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) DYKM1636A, UDI-DI: 10889942925858(each), 40889942925859(case), Lot Number: 25ABW688; 2) DYKM1636A, UDI-DI: 10889942925858(each), 40889942925859(case), Lot Number: 23LBT438; 3) DYKM1881A, UDI-DI: 10198459025174(each), 40198459025175(case), Lot Number: 24KBS611; 4) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 25BBB106; 5) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24KBJ751; 6) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24LBO630; 7) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24ABB622; 8) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBG290; 9) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBG291; 10) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBT163; 11) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24EBM679; 12) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24FBL963; 13) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV589; 14) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV590; 15) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV591; 16) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV592; 17) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3062-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.