FDASeptember 11, 2020device
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
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
- FDAETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH2025-03-07
- FDAPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM2025-03-07
- FDAPDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-12025-03-07
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