Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol — Class II medical device recall Z-0178-2021
Ongoing recall by Bien-Air Surgery Sa, reported 2020-10-28, distributed nationwide. The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
| Recall number | Z-0178-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bien-Air Surgery Sa, Le Noirmont, N/A, Switzerland |
| Recall initiated | 2020-09-11 |
| Classified | 2020-10-21 |
| Reported by FDA | 2020-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,120 foot |
| Serial numbers | 16A0005, 16A0009, 16A0010, 16A0011, 16A0014, 17D0011, 17G0006, 18D0006, 18D0007, 18D0008, 18D0009, 18D0010, 18D0013, 18D0014, 18D0015, 18D0016, 18D0017, 18D0018, 18D0019, 18D0020, 18D0021, 18D0022, 18D0023, 18D0024, 18D0025 and 5 more |
| Model numbers | 1600686, 1600686-001 |
Product
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
Reason for recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0178-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.