CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

InSure ONE Fecal Immunochemical Test recalled by Enterix

Enterix is recalling InSure ONE Fecal Immunochemical Test, distributed nationwide in the US. The recall was initiated on 17 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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.

Quantity recalled201,426 test kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0725-2026
FDA event ID: 97802
Recalling firm: Enterix, Edison, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 17 Sep 2025
FDA classified: 28 Nov 2025
Reported: 10 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Sep 2025	Recall initiated by company
28 Nov 2025	Classified by FDA	+72 days
10 Dec 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.

Nationwide California Florida Georgia Illinois Indiana Kentucky Massachusetts North Carolina New Jersey Nevada New York Ohio Pennsylvania Texas Virginia Washington West Virginia

Questions about this recall

Is InSure ONE Fecal Immunochemical Test recalled?

Yes. Enterix recalled InSure ONE Fecal Immunochemical Test on 17 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0725-2026.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Enterix

All 2

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Device	CLASS II	InSure ONE Test Strips vials-fecal immunochemical test recalled	Enterix	Lead & Heavy Metals	Nationwide

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