Steritec Products Mfc. Co., Inc.

Complete recall history across all FDA and CPSC categories — 8 total recalls

Steritec Products Mfc. Co., Inc. 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 (8)

FDA medical device enforcement actions by Steritec Products Mfc. Co., Inc.

Date Product Reason Class
Jun 10, 2013 Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL ... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... Class II
Jun 10, 2013 Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Pr... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... Class II
Jun 10, 2013 EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 E... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... Class II
Jun 10, 2013 Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriT... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... Class II
Jun 10, 2013 Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... Class II
Jun 10, 2013 Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... Class II
Jun 10, 2013 Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributo... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... Class II
Jun 10, 2013 Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributo... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a pr... 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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