CLASS II ONGOING Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Body Weight Support (BWS) Light recalled by Motek Medical B.v
Motek Medical B.v is recalling Body Weight Support (BWS) Light, distributed nationwide in the US. The recall was initiated on 29 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2135-2020
- FDA event ID
- 85301
- Recalling firm
- Motek Medical B.v, Amsterdam, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2019
- FDA classified
- 27 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Device type
- Other Medical Devices
Timeline
| 29 Jul 2019 | Recall initiated by company | |
| 27 May 2020 | Classified by FDA | +303 days |
| 3 Jun 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distributions including in the states of AZ, CA, FL, KY, MA, MI, NJ, NY, NC, and OH. The countries of Argentina, Austria, Belgium, China, Curacao, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Switzerland, and United Arab Emirates.
Nationwide ArizonaCaliforniaFloridaKentuckyMassachusettsMichiganNorth CarolinaNew JerseyNew YorkOhio
Questions about this recall
Is Body Weight Support (BWS) Light recalled?
Yes. Motek Medical B.v recalled Body Weight Support (BWS) Light on 29 Jul 2019. The recall is Class II and its status is Ongoing. Recall number Z-2135-2020.
Why was it recalled?
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.
Which lots are affected?
AS9924-00-0002, RB011-00-0005,RB011-00-0006, RB011-00-0010, RB011-00-0012, RB011-00-0015, RB011-00-0017, RB011-00-0018, RB011-00-0019, RB011-00-0020, RB011-00-0021, RB011-0022, RB011-0023, RB011-0024, RB011-0025, RB011-0026, RB011-0027, RB011-0028, RB011-0029, RB011-0030, RB011-0031, RB011-0032, RB011-0033, RB011-0034, RB011-0035, RB011-0036, RB011-0037, RB011-0038, RB011-0039, RB011-0040, RB011-0041, RB011-0042, RB011-0044, RB011-0045, RB011-0046, RB011-0047, RB011-0048, RB011-0049, RB011-0050, RB011-0051, RB011-0052, RB011-0053, RB011-0054, RB011-0055, RB011-0056, RB011-0057, RB011-0058, RB011-0059, RB011-0060, RB011-0061, RB011-0062, RB011-0063, RB011-0064, RB011-0065, RB011-0066, RB011-0067, RB011-0068, RB011-0069, RB011-0070, RB011-0071, RB011-0072, RB011-0073, RB011-0074, RB011-0075, RB011-0076, RB011-0077, RB011-0078, RB011-0079, RB011-0080, RB011-0081, RB011-0082, RB011-0083, RB011-0084, RB011-0085, RB011-0086, RB011-0087, RB011-0088, RB011-0089, RB011-0090, RB011-0091, and RB011-0092.
Where was it sold?
Worldwide distribution - US Nationwide distributions including in the states of AZ, CA, FL, KY, MA, MI, NJ, NY, NC, and OH. The countries of Argentina, Austria, Belgium, China, Curacao, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Switzerland, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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