FDA Medical devices recall ·
Medica Capillary Tubes recall
- Recall number
- Z-1370-2026
- Date
- (initiated December 31, 2025)
- Company / brand
- Medica Corporation
5 Oak Park Dr, Bedford, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,578 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
Distribution
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1370-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.