Blue Ortho

Complete recall history across all FDA and CPSC categories — 3 total recalls

Blue Ortho 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 Blue Ortho

Date Product Reason Class
Aug 30, 2024 Predict+ is a data-driven, clinical decision support tool that uses machine l... Predict+ is being recalled for lack of pre-market clearance/approval. Class II
Sep 10, 2020 Instructions For Use document of the GPS Trackers. Appropriateness of the language used in the Tracker reprocessing instruction.... Class II
Sep 22, 2019 Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indica... The navigated values displayed when using the LPI instrumentation are incorre... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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