Bien-Air Surgery Sa

Complete recall history across all FDA and CPSC categories — 5 total recalls

Bien-Air Surgery Sa 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 (5)

FDA medical device enforcement actions by Bien-Air Surgery Sa

Date Product Reason Class
Sep 11, 2020 Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Produc... The magnet located inside the foot pedal may come off and may result in unatt... Class II
Sep 11, 2020 Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Us... The magnet located inside the foot pedal may come off and may result in unatt... Class II
Sep 11, 2020 Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: i... The magnet located inside the foot pedal may come off and may result in unatt... Class II
Sep 11, 2020 Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product U... The magnet located inside the foot pedal may come off and may result in unatt... Class II
Sep 11, 2020 Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Pr... The magnet located inside the foot pedal may come off and may result in unatt... 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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