FDASeptember 11, 2020device
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
What to do
FDA enforcement status: Ongoing
Brands named
bien air surgery sabienbien air
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCVornado Air Recalls SRTH Small Room Tower Heaters Due to Fire Hazard2026-06-04
- FDAECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC802025-09-11
- CPSCMidea Recalls About 1.7 Million U and U+ Window Air Conditioners Due to Risk of Mold Exposure2025-06-05
- FDAEndopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR352025-04-22
- FDAPDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP2025-03-07
- FDAPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM2025-03-07
- FDAETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH2025-03-07
- FDAPDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-12025-03-07
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