Quick Facts at a Glance
- Recall Date
- September 17, 2025
- Hazard Level
- HIGH
- Brand
- Enterix
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Enterix
- Product type
- Fecal Immunochemical Test (FIT) Kit
- Model numbers
- 90010, 90025, 90030
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 17, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Enterix, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
InSure ONE is a fecal immunochemical test used to screen for occult blood in stool. It qualitatively detects human hemoglobin in fecal samples.
Why This Is Dangerous
The product failed sensitivity testing with Test Card Lot TT241102, which may yield false negative results and delay detection of conditions.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers could receive falsely normal results, potentially delaying diagnosis and treatment.
Practical Guidance
How to identify if yours is affected
- Stop using the product immediately.
- Identify if you have Model 90010, 90025, or 90030.
- Check lot production dates: 2025-07-23 to 2025-09-12 and Test Card Lot TT241102.
- Review the recall notice for specific steps provided by Enterix.
- Follow the manufacturer recall instructions or contact Enterix for guidance.
Where to find product info
Official recall notices and guidance are issued by Enterix via email and FDA recall page. The listed GTINs are 10850093003313 (90010), 20850093003310 (90025), 00850093003279 (90030).
What timeline to expect
Refunds or replacements, if offered, typically follow the company’s recall process. Consumers should expect updates via recall emails.
If the manufacturer is unresponsive
- Escalate to relevant recall authorities (CPSC or FDA)
- File a consumer complaint with recall authority
- Preserve all recall communications for records
How to prevent similar issues
- Verify test card lot numbers before use in any diagnostic kit
- Purchase from reputable sources and verify recall status before use
- Stay informed through official recall notices and FDA updates
Documentation advice
Keep the purchase receipt, packaging, recall notices, GTINs, model numbers, and any correspondence with Enterix or healthcare providers.
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Product Details
Model 90010 Insure ONE POL Patient Kit 10 pack. GTIN 10850093003313. All lots produced 2025-07-23 to 2025-09-12 with Test Card Lot TT241102. Model 90025 Insure ONE POL Patient Kit 25 pack. GTIN 20850093003310. All lots produced 2025-07-23 to 2025-09-12 with Test Card Lot TT241102. Model 90030 InSure ONE POL Combo Pack. GTIN 00850093003279. All lots produced 2025-07-23 to 2025-09-12 with Test Card Lot TT241102. Distribution: Worldwide. US states include CA, FL, GA, IL, IN, KY, MA, NV, NJ, NY, NC, OH, PA, TX, WA, WV; Philippines included.
Reported Incidents
No injuries or incidents have been reported in the recall notice.
Key Facts
- 201,426 total test kits recalled
- Test Card Lot TT241102 implicated
- Lots produced 2025-07-23 to 2025-09-12
- Worldwide distribution including 15 U.S. states and the Philippines
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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