FDA Device Recall Z-1716-2026

Device

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.

Lot / serial / GTIN: Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 24BBI341; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23LBP066; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23KBS305; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23JBA062; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23HBR594; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23DBR051; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 24ABO014; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23KBW878; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23HBP761; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23FBW006; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23DBF403; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25KMD905; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25IMD215; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25GMI326; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25FMI653; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25EMH566; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25DMI277; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25AMI608; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMH838; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMB458; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24JME629; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GME647; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB984; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB351; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24EMF938; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24DMH385; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMH336; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMF956; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24BMA898; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24AMA108; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23HMH132; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GMH036; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GME698; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23FMF802; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23EMJ218; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24JMD976; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24HMA010; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMG026; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMB098; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24FMF601; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24EMB438; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24BMA764; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23LME233; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23JMH698; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23IMD171; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23GMD850; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23FMF778; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23EMG560; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25LMG779; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25IMJ214; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25HMF990; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25EMI063; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25DMB127; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25BMF602; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24LMF104; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24KMD144; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24JMA170; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24HMH276; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24HMA390; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24FMD853; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24DMJ147; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24CMH759; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24BMA225; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23LMB166; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23KMH325; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23IME127; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23HME466; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23FMJ772; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23FMB456; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23EMC182; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23DMH934; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25JMI272; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25HMG164; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25HMF202; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25LBB437; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25HBV263; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR191; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR194; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR437; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25EBO829; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25BBR177; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24JBX749; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24JBG123; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24IBJ506; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24FBT677; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24FBH497; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24DBL409; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24BBT394; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24ABR246; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23LBK160; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23KBJ685; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23IBU014; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23IBG647; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23HBB827; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23FBU409; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 24ABQ959; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23KBF277; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23IBR043; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23HBI873; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23GBA252; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23EBM886; Medline SKU VASC1170A, UDI/DI each 10193489774863, UDI/DI case 40193489774864, Lot Number 25HMD546; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 25HBL365; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 25GBL071; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 24GBY914.

Quantity: 17902 kits

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.

Recall record

Recall number

Z-1716-2026

Classification

Class I

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution

Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).

Recall initiated

2026-02-27

Classified by FDA Center

2026-04-07

FDA published

2026-04-15

Recalling firm

Medline Industries, LP

Firm location

Northfield, IL