Medica Capillary Tubes recallZ-1370-2026 · Medica Corporation · initiated Dec 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medica Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
An URGENT FIELD SAFETY NOTICE was sent to consignees on 01/09/25 informing them that potassium results obtained using affected devices in capillary mode may be falsely elevated. The FSN instructed consignees not to report potassium results obtained in capillary mode using affected lots on the Easy Stat Analyzer. The FSN is to be forwarded to end users and to where product was further distributed. Consignees are to contact their local representative with any questions.
Recall details
- Recall number
- Z-1370-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 31, 2025
- Posted by the FDA
- Feb 13, 2026
- Recalling firm
- Medica Corporation
- Quantity
- 1,578 units
- Product code
- CEM
- FDA submissions
- K021515
- Distribution
- International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Product description
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Code information (models, lots, serial numbers)
Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Globe Scientific 51635Globe Scientific Inc. · Tube, Collection, Capillary Blood1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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