Body Weight Support — Class II medical device recall Z-2135-2020
Ongoing recall by MOTEK MEDICAL B.V., reported 2020-06-03, distributed nationwide. The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light tha
| Recall number | Z-2135-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MOTEK MEDICAL B.V., Amsterdam, N/A, Netherlands |
| Recall initiated | 2019-07-29 |
| Classified | 2020-05-27 |
| Reported by FDA | 2020-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, CH, CN, CW, CZ, DE, DK, EC, EG, ES, FI, FR, JP, KR, MX, NL, RU |
| Quantity | 80 units |
| Reason classes | device malfunction |
| Model numbers | RB011 |
Product
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.
Reason for recall
The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.
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-2135-2020. 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.