Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm… — Class II medical device recall Z-0091-2021
Terminated recall by Mizuho OSI, reported 2020-10-21, distributed nationwide. Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead
| Recall number | Z-0091-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mizuho OSI, Union City, CA, United States |
| Recall initiated | 2019-10-14 |
| Classified | 2020-10-09 |
| Reported by FDA | 2020-10-21 |
| Terminated | 2023-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, DE, GB, IL, KR, NZ, PL, ZA |
| Quantity | 174 arms |
| Serial numbers | 201, 234, 235, 248, 255, 341, 448 |
| Model numbers | 7887-050, 7887-050R |
Product
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
Reason for recall
Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism
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-0091-2021. 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.