| | Class 1 Device Recall Medline medical convenience kits |  |
| Date Initiated by Firm | February 27, 2026 |
| Date Posted | April 07, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1716-2026 |
| Recall Event ID |
98598 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
|
| 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. |
| Code Information |
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.
|
| FEI Number |
1417592
|
Recalling Firm/ Manufacturer |
Medline Industries, LP 3 Lakes Dr Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay 866-359-1704 |
Manufacturer 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. |
FDA Determined Cause 2 | Under Investigation by firm |
| Action | Medline Industries, LP issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 2/27/2026 via USPS and email. The notice explained the issue, risk associated with syringe disconnection and loose connection, and request customers remove and destroy all Namic RA Syringes. Over-labels will be provided for any affected kits on hand stating that the affected syringes must be removed and discarded from further use. The only exception is in rare circumstances where angiography is urgently required, no alternative device is available, and postponing the procedure would place the patient at significant risk.
Required Action: Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity in Commerce | 17902 kits |
| 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). |
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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