Class II U.S. Food and Drug Administration

Enterix, Inc. InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE recall: InSure ONE failed sensitivity testing when used with Test Card Lot T241102

Recall published 11 months ago

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

The hazard: Device malfunction

This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

What the notice says: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0725-2026
Published
December 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Enterix, Inc.
Product type
Medical devices
Units affected
201,426 test kits
Distribution
Nationwide
Made in
United States
Lot / code info
1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.
UPC codes
10850093003313, 20850093003310, 00850093003279

Products covered by this recall

InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.

Check your product

The notice names 12 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.

  • 10850093003313
  • 20850093003310
  • 00850093003279

Lot or batch code

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

  • 23
  • 2025-9
  • 12
  • 42

Model or item number

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

  • 90010
  • 90025
  • 90030

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 pack
  • 25 Pack

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 Malfunction

Enterix, Inc. — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  3. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  4. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.

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: Enterix, Inc. — 236 Fernwood Ave, Edison, NJ, 08837-3839

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 Enterix, Inc. medical devices recalled?

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10850093003313, 20850093003310, 00850093003279; lot code 23, 2025-9, 12; model number 90010, 90025, 90030. 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 listed 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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