OPTI Medical Systems, Inc
Complete recall history across all FDA and CPSC categories — 3 total recalls
OPTI Medical Systems, 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 (3)
FDA medical device enforcement actions by OPTI Medical Systems, Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 25, 2021 | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 | The firm identified a precipitation issue which may cause late Ct reactors (a... | Class II |
| Aug 9, 2013 | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTI... | OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorr... | Class II |
| Jul 3, 2012 | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables u... | The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high con... | 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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