CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report
Leaky Gut Test recalled by Get Tested International Ab
Get Tested International Ab is recalling Leaky Gut Test, distributed nationwide in the US. The recall was initiated on 3 Nov 2025 and the FDA has classified it as Class II.
Check your package
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-0787-2026
- FDA event ID
- 97896
- Recalling firm
- Get Tested International Ab, Vastervik
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Nov 2025
- FDA classified
- 1 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Nov 2025 | Recall initiated by company | |
| 1 Dec 2025 | Classified by FDA | +28 days |
| 10 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Distribution without premarket approval/clearance.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Leaky Gut Test
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Leaky Gut Test recalled?
Yes. Get Tested International Ab recalled Leaky Gut Test on 3 Nov 2025. The recall is Class II and its status is Ongoing. Recall number Z-0787-2026.
Why was it recalled?
Distribution without premarket approval/clearance.
Which lots are affected?
EAN: 616612785923; SKU: A500; UDI-DI: None; Lot/Serial Number: All Lots;
Where was it sold?
US Nationwide distribution.
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.
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