FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline medical convenience kits recalled for syringe adapter disconnection risk
OTHERNationwide distribution
Stop using affected Medline medical kits
Medline Industries has recalled multiple medical convenience kits that contain NAMIC Angiographic Rotating Adaptor syringes. The syringe's rotating adapter may unwind during use, causing the connection between the syringe and manifold to loosen or fully disconnect. This could interrupt fluid flow or medication delivery during procedures.
- Check if you have any affected Medline medical kits by matching your SKU number and lot number to the recall list
- Stop using affected kits immediately
- Contact Medline Industries with your SKU and lot number for a replacement or instructions
- Notify your healthcare facility's materials management or biomedical team if you work in a hospital or clinic
Hazard
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.
Sold states
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).
Affected count
79843 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131209; 4. MTS LHK, Medline SKU # 60160075; 5. MTS LHK, Medline SKU # 60161954; 6. MTO LHK, Medline SKU # 60230148; 7. GENERAL SURGERY TRAY, Medline SKU # 00-500510I; 8. BIOBURDEN TEST KIT - 686, Medline SKU # BIOB686; 9. RADIO ANGIO UNIV HOSP PACK-LF, Medline SKU # DYNJ0376145M; 10. SPECIALS PACK-LF, Medline SKU # DYNJ0392706K; 11. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426O; 12. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426P; 13. CARDIAC CATH PACK, Medline SKU # DYNJ07953N; 14. CATH PACK-LF, Medline SKU # DYNJ0803367J; 15. E.P. TRAY, Medline SKU # DYNJ19343J; 16. CARDIAC CATH PACK, Medline SKU # DYNJ20898T; 17. CATH LAB TRAY, Medline SKU # DYNJ24250G; 18. CATH LAB PACK-LF, Medline SKU # DYNJ38333D; 19. CATH LAB PACK-LF, Medline SKU # DYNJ38333F; 20. EP IMPLANT PACK-LF, Medline SKU # DYNJ38910D; 21. ADULT CATH LAB PACK, Medline SKU # DYNJ40380J; 22. CRANIOTOMY PACK-LF, Medline SKU # DYNJ43403D; 23. LAP CHOLE PACK, Medline SKU # DYNJ48487F; 24. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779G; 25. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779I; 26. HYBRID, Medline SKU # DYNJ57049N; 27. SPECIALS PK, Medline SKU # DYNJ57713C; 28. SPECIALS PK, Medline SKU # DYNJ57713D; 29. SPECIALS PK, Medline SKU # DYNJ57713F; 30. CARDIAC CATH LAB, Medline SKU # DYNJ57748A; 31. TAVR PACK, Medline SKU # DYNJ58771G; 32. CATH PACK GWV, Medline SKU # DYNJ59229F; 33. HEART CATH PACK, Medline SKU # DYNJ61294F; 34. CATH LAB PACK, Medline SKU # DYNJ61353C; 35. DEVICE IMPLANT PACK, Medline SKU # DYNJ64636A; 36. CUSTOM PROCEDURE KIT, Medline SKU # DYNJ65277A; 37. GENERAL VASCULAR PACK RFID-V2, Medline SKU # DYNJ66442F; 38. CARDIAC CATH PACK, Medline SKU # DYNJ69845C; 39. OMF MINOR PACK, Medline SKU # DYNJ83991C; 40. HEART CATH PACK, Medline SKU # DYNJ84133B; 41. SPECIAL PROCEDURES, Medline SKU # DYNJ85425B; 42. PRIMARY PACK, Medline SKU # DYNJT3093; 43. CARDIAC CATH PACK, Medline SKU # DYNJT3522A; 44. CARDIAC CATH PACK, Medline SKU # DYNJT3522B; 45. TOTAL KNEE PACK, Medline SKU # DYNJT4069; 46. CARDIAC CATH PACK, Medline SKU # DYNJT5685; 47. CATH PACK, Medline SKU # DYNJT6544; 48. PACK CARDIAC CATH, Medline SKU # DYNJT7591; 49. OBL CATH VEIN PACK, Medline SKU # DYNJT7863; 50. TUMESCENT SYRINGE KIT, Medline SKU # DYNJTUMSYR; 51. CSTM LH KIT, Medline SKU # VASC1054; 52. LHK, Medline SKU # VASC1130A; 53. MANIFOLD KIT, Medline SKU # VASC1137A; 54. LHK, Medline SKU # VASC1299A; 55. LHK, Medline SKU # VASC1399B; 56. LHK, Medline SKU # VASC1403; 57. IR 2 PORT, Medline SKU # VASC1404; 58. LHK, Medline SKU # VASC1405; 59. LHK, Medline SKU # VASC1455A; 60. TWO PORT MANIFOLD KIT, Medline SKU # VASC1496; 61. RHK, US, NAMIC MANIFOLD, Medline SKU # VASC1502; 62. LHK, Medline SKU # VASC1555; 63. 4 VALVE,PERC,MANIFOLD,KIT, Medline SKU # VASC1609; 64. LHK, Medline SKU # VASC1668; 65. LHK, Medline SKU # VASC1694; 66. LHK, Medline SKU # VASC1805; 67. TVR, Medline SKU # VASC1816.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1724-2026More Medline Industries, LP recalls
- FDA-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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