Medica Corporation

Complete recall history across all FDA and CPSC categories — 4 total recalls

Medica Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (4)

FDA medical device enforcement actions by Medica Corporation

Date Product Reason Class
Dec 31, 2025 Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. A systematic positive bias of up to 20% was identified across the reportable ... Class II
Feb 6, 2019 Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical ... Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL re... Class II
Nov 21, 2017 Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is mar... The firm has initiated a field recall of the Wash1 Kit REF 10680 due to repo... Class II
Apr 11, 2017 EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containin... Patient results determined using this calibrator lot might deviate up to 20%.... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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