Class I U.S. Food and Drug Administration

Medline medical convenience kits, containing Namic Angiographic recall: Medline Industries, LP has identified through post-market surveillance

Recall published 6 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1715-2026
Published
April 15, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
1698 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25IBN161; Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25GBF769; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25HBN798; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25GBL527; Medline SKU VASC1198, UDI/DI each 10193489664263, UDI/DI case 40193489664264, Lot Number 25GDA142; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25IBP989; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25GBL526; Medline SKU VASCSLPON1, UDI/DI each 10889942405510, UDI/DI case 40889942405511, Lot Number 25GBL070.
UPC codes
10889942464722, 40889942464723, 10889942611751, 40889942611752, 10193489664263, 40193489664264, 10889942405503, 40889942405504, 10889942405510, 40889942405511

Products covered by this recall

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.

Check your product

The notice names 33 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10889942464722
  • 40889942464723
  • 10889942611751
  • 40889942611752
  • 10193489664263
  • 40193489664264
  • 10889942405503
  • 40889942405504
  • 10889942405510
  • 40889942405511

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25IBN161
  • 25GBF769
  • 25HBN798
  • 25GBL527
  • 25GDA142
  • 25IBP989
  • 25GBL526
  • 25GBL070. — 1698 kits

Model or item number

On the rating label, the box or the instruction sheet.

  • VASC1061
  • VASC1074
  • VASC1198
  • VASCSHPOFF1
  • UDI
  • DI each 108
  • DI each 10889942464722
  • DI case 4
  • DI each 10889942611751
  • DI each 10193489664263
  • DI each 10889942405503
  • DI cas
  • VASCSLPON1
  • DI each 10889942405510
  • DI case

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10889942464722, 40889942464723, 10889942611751; lot code 25IBN161, 25GBF769, 25HBN798; model number VASC1061, VASC1074, VASC1198. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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