Medline Industries, LP recalls NAMIC Angiographic Control Syringe
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.
Lot / code information
- Lot #
0000077029, 0000081537, 0000084335, 0000087347, 0000089563, 0000113792 — +9 moreShow all
0000077029, 0000081537, 0000084335, 0000087347, 0000089563, 0000113792, 0000115753, 0000122956, 0000127785, 0000131986, 0000158748, 0000175535, 0000187926; 2. Medline SKU 70084007, UDI/DI each 10193489065893, UDI/DI case 30193489065897- Lot #
0000078186, 0000081539, 0000084274, 0000086756, 0000089554, 0000094842 — +29 moreShow all
0000078186, 0000081539, 0000084274, 0000086756, 0000089554, 0000094842, 0000096918, 0000105613, 0000109479, 0000111244, 0000114562, 0000115421, 0000117317, 0000118251, 0000120265, 0000120769, 0000121714, 0000123466, 0000124589, 0000131984, 0000131989, 0000138071, 0000140322, 0000142850, 0000147002, 0000152069, 0000162694, 0000173507, 0000174662, 0000174773, 0000176555, 0000178806, 0000189895; 3. Medline SKU 70084017, UDI/DI each 10193489065916, UDI/DI case 20193489065913- Lot #
- 0000084509, 0000086823, 0000095687, 0000165551, 0000165868, 0000166300; 4. Medline SKU 80083007, UDI/DI each 10193489066753, UDI/DI case 30193489066757
- Lot #
- 0000097388, 0000127072, 0000135012, 0000137004; 5. Medline SKU 80084007, UDI/DI each 10193489066791, UDI/DI case 30193489066795
- Lot #
0000080553, 0000080919, 0000082969, 0000085041, 0000088044, 0000094514 — +91 moreShow all
0000080553, 0000080919, 0000082969, 0000085041, 0000088044, 0000094514, 0000099870, 0000101882, 0000102372, 0000105155, 0000107328, 0000109442, 0000112810, 0000112966, 0000114317, 0000115744, 0000117572, 0000118722, 0000118962, 0000119950, 0000120931, 0000121305, 0000121393, 0000122583, 0000122606, 0000123102, 0000126198, 0000126566, 0000127132, 0000130798, 0000131678, 0000132838, 0000137176, 0000139543, 0000140507, 0000142057, 0000142279, 0000143110, 0000143264, 0000143714, 0000148872, 0000150059, 0000150488, 0000151054, 0000151295, 0000151300, 0000151768, 0000152754, 0000153438, 0000154148, 0000156028, 0000158045, 0000158122, 0000159113, 0000159652, 0000160479, 0000160753, 0000161269, 0000162083, 0000162090, 0000162336, 0000162895, 0000164540, 0000164541, 0000166504, 0000166983, 0000167995, 0000168000, 0000169147, 0000169560, 0000169793, 0000170823, 0000171778, 0000173402, 0000174087, 0000174697, 0000174747, 0000176011, 0000176240, 0000176850, 0000177923, 0000179193, 0000179414, 0000180511, 0000182186, 0000182779, 0000182782, 0000185643, 0000186234, 0000186874, 0000187362, 0000187363, 0000188837, 0000188842, 0000188845; 6. Medline SKU 80084017, UDI/DI each 10193489066814, UDI/DI case 20193489066811- Lot #
0000101535, 0000103862, 0000105095, 0000106954, 0000108237, 0000122887 — +21 moreShow all
0000101535, 0000103862, 0000105095, 0000106954, 0000108237, 0000122887, 0000126590, 0000127159, 0000128360, 0000128852, 0000132717, 0000134047, 0000135616, 0000140813, 0000144899, 0000148530, 0000149322, 0000152430, 0000161279, 0000164538, 0000169107, 0000173193, 0000173256, 0000182141, 0000183619, 0000187345, 0000188399
What the firm is doing
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.
DistributionShow detailsHide
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).
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1713-2026
- FDA 510(k) clearance · K113198The device's official FDA premarket clearance record
- FDA device classification · DXTOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1650The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class I recalls
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a man…
- Pulmonary Valve Prosthesis Percutaneously Delivered
- Process control
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination