FDA Medical devices recall ·
Convenience kits containing select SKUs of 10mL Polycarbonate Colored… recall
- Recall number
- Z-2595-2026
- Date
- (initiated February 27, 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
- 113, 843 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Why was it recalled?
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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
DYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336
Distribution
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
States: Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island Tennessee Texas Virginia Wisconsin Wyoming
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-2595-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.