Medline medical convenience kits — Class I medical device recall Z-1716-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-15, distributed nationwide. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotatin
| Recall number | Z-1716-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-27 |
| Classified | 2026-04-07 |
| Reported by FDA | 2026-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, JP, KR, LK, NL, PK, SG, SK |
| Quantity | 17,902 kits |
| UPC / GTIN / UDI-DI | 10193489253146, 10193489297393, 10193489460872, 10193489461176, 10193489609851, 10193489759303, 10193489774863, 10193489791860, 10193489799828, 10889942748426, 40193489253147, 40193489297394, 40193489460873, 40193489461177, 40193489609852, 40193489759304, 40193489774864, 40193489791861, 40193489799829, 40889942748427 |
| Lot numbers | 23DBF403, 23DBR051, 23DMH934, 23EBM886, 23EMC182, 23EMG560, 23EMJ218, 23FBU409, 23FBW006, 23FMB456, 23FMF778, 23FMF802, 23FMJ772, 23GBA252, 23GMD850, 23GME698, 23GMH036, 23HBB827, 23HBI873, 23HBP761, 23HBR594, 23HME466, 23HMH132, 23IBG647, 23IBR043, 23IBU014, 23IMD171, 23IME127, 23JBA062, 23JMH698, 23KBF277, 23KBJ685, 23KBS305, 23KBW878, 23KMH325, 23LBK160, 23LBP066, 23LMB166, 23LME233, 24ABO014 and 65 more |
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.
Reason for recall
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
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-1716-2026. 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.