Recall Z-2590-2026
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. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Codes / lots: DYNJ85743 UDI-DI 10195327542337 Lots 24ABP082 24BBA479 DYNJ81610C UDI-DI 10195327556938 Lot 24BBB405 DYNJ0843063L UDI-DI 10195327567071 Lots 23LDB992 24BDA641 24BDA782 24FDA795 24GDB014 24HDB074 DYNJ54755J UDI-DI 10195327549909 Lots 24ABJ741 24CBI600 24EBA488 24FBM084 24GBN355 24HBH571 DYNJ61383C UDI-DI 10195327593346 Lot 24CLA801 DYNJ0843339O UDI-DI 10195327567057 Lots 24CDB480 24DDA248 24GDB068 DYNJ61907A UDI-DI 10195327542450 Lot 24ABP069 DYNJ0429121L UDI-DI 10195327587697 Lot 24BMH315
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-2590-2026
- Initiated
- February 27, 2026
- Posted by FDA
- June 25, 2026
- Product code
- LRO – General Surgery Tray
- 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-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-2595-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC…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 |