Data Foundry

Medical device recalls 2026

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 numberZ-1716-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-02-27
Classified2026-04-07
Reported by FDA2026-04-15
DistributedNationwide (US)
Countries outside the USAE, AU, CA, JP, KR, LK, NL, PK, SG, SK
Quantity17,902 kits
UPC / GTIN / UDI-DI10193489253146, 10193489297393, 10193489460872, 10193489461176, 10193489609851, 10193489759303, 10193489774863, 10193489791860, 10193489799828, 10889942748426, 40193489253147, 40193489297394, 40193489460873, 40193489461177, 40193489609852, 40193489759304, 40193489774864, 40193489791861, 40193489799829, 40889942748427
Lot numbers23DBF403, 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.