Class II U.S. Food and Drug Administration

Terumo Medical Corporation Glidesheath Slender A-Kit 6F 10CM .021GW. 5 units per box recall: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire

Recall published 2 months ago

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

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-2930-2026
Published
August 19, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Terumo Medical Corporation
Product type
Medical devices
Units affected
7,490 units
Distribution
Nationwide
Made in
United States
Lot / code info
Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
UPC codes
30389701011975, 00389701011974

Products covered by this recall

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Check your product

The notice names 5 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.

  • 30389701011975
  • 00389701011974

Lot or batch code

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

  • 0001441871. — 7
  • 490 units

Model or item number

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

  • 60-1060. Shelfbox UDI-DI

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

Terumo Medical Corporation — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Terumo Medical Corporation — 950 Elkton Blvd, Elkton, MD, 21921-5322

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 Terumo Medical Corporation medical devices recalled?

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 30389701011975, 00389701011974; lot code 0001441871. — 7, 490 units; model number 60-1060. Shelfbox UDI-DI. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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