Recall Z-2595-2026
Medline Industries, LP · initiated February 27, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Codes / lots: DYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336
Reason for recall
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA-determined cause: No Marketing Application
Action taken
This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.
Details
- Recall number
- Z-2595-2026
- Initiated
- February 27, 2026
- Posted by FDA
- June 25, 2026
- Product code
- MCY – Wound Dressing Kit
- Quantity
- 113, 843 kits
- 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.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2581-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2582-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2583-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2584-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2585-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2586-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2587-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2588-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2589-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2590-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2591-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2592-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2593-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2594-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |
| Z-2596-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | 02/27/2026Open, Classified |