Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal — Class II medical device recall Z-0180-2021
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-0180-2021 |
|---|---|
| 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) |
| Serial numbers | 16H0001, 16H0002, 16H0003, 16H0004, 16H0005, 16H0006, 16H0007, 16H0008, 16H0009, 16H0010, 16H0011, 16H0012, 16H0013, 16H0014, 16H0015, 16H0016, 16H0017, 16H0018, 16H0019, 16H0020, 16H0021, 16H0022, 16H0023, 16H0024, 16H0025 and 475 more |
| Model numbers | 1600998, 1600998-001, SA-102 |
Product
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
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-0180-2021. 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.