Convenience kits containing select SKUs of 10mL Polycarbonate Colored… — Class II medical device recall Z-2583-2026
Ongoing recall by Medline Industries, LP, reported 2026-07-01, distributed nationwide. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products n
| Recall number | Z-2583-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-27 |
| Classified | 2026-06-25 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB |
| Quantity | 113,843 kits |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 10193489395464, 10193489397420, 10193489631289, 10193489908954, 10195327014469, 10195327154585, 10195327187866, 10195327187965, 10195327219925, 10195327286460, 10195327405519, 10195327406004, 10195327466992, 10195327556723, 10195327556907, 10889942275700 |
| Lot numbers | 21BBG946, 21DBD729, 21EBO606, 21FBM893, 21GBT443, 21HBD986, 21HBN881, 21HBN882, 21HBO570, 21IBE897, 21JBA979, 21JBK103, 21KBA397, 21KBA398, 21KBA400, 21KBO309, 21LBC591, 21LBC610, 21LBG289, 21LBH668, 22BBV026, 22CBV042, 22CBV171, 22CME902, 22DMI216, 22DMI217, 22EMB282, 22EME050, 22EMH096, 22FMC402, 22GMG222, 22GMG562, 22GMG599, 22HMG258, 22IMF392, 22IMF393, 22JME891, 22JMG893, 22LMA455, 22LME862 and 53 more |
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2583-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.