CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V recalled
Sonesta Medical Ab is recalling Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V, distributed in Massachusetts. The recall was initiated on 8 Mar 2017 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-1894-2017
- FDA event ID
- 77075
- Recalling firm
- Sonesta Medical Ab, Bromma
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2017
- FDA classified
- 28 Apr 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Mar 2017 | Recall initiated by company | |
| 28 Apr 2017 | Classified by FDA | +51 days |
| 10 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
Product as listed by the FDA
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
Where it was distributed
Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
Questions about this recall
Is Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V recalled?
Yes. Sonesta Medical Ab recalled Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V on 8 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1894-2017.
Why was it recalled?
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
Which lots are affected?
12-00001-110V 12-00011-110V 23-00002-220V (Demo Product) 12-00002-110V 12-00012-110V 23-00001-220V 12-00003-110V 12-00013-110V 23-00003-220V 12-00004- 110V 12-00014-110V 23-00004-220V 12-00005-110V 12-00015-110V 23-00005-220V 12-00006-110V 12-20001-110V 23-00006-220V 12-00007-110V 12-20002-110V 23-00009-220V 12-00008-110V 12-20003-110V 23-00020-220V 12-00009-110V 12-20004 -110V 23-20001-220V 12-00010-110V 23-20002-220V
Where was it sold?
Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
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.
More recalls from Sonesta Medical Ab
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number recalled | Sonesta Medical AB | Device Malfunction | NH |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |