CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Capillary Tubes recalled by Medica
Medica is recalling Capillary Tubes. The recall was initiated on 31 Dec 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-1370-2026
- FDA event ID
- 98315
- Recalling firm
- Medica, Bedford, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Dec 2025
- FDA classified
- 13 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Dec 2025 | Recall initiated by company | |
| 13 Feb 2026 | Classified by FDA | +44 days |
| 25 Feb 2026 | 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
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Product as listed by the FDA
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Where it was distributed
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Questions about this recall
Why was it recalled?
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Which lots are affected?
Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
Where was it sold?
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
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 26 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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