Arthex S3 Arm Sleeve Connector — Class II medical device recall Z-0928-2017
Terminated recall by Allen Medical Systems, Inc., reported 2017-01-04, distributed in FL. During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of
| Recall number | Z-0928-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allen Medical Systems, Inc., Acton, MA, United States |
| Recall initiated | 2016-11-23 |
| Classified | 2016-12-29 |
| Reported by FDA | 2017-01-04 |
| Terminated | 2019-08-20 |
| Distributed | FL |
| Quantity | 420 devices |
| Model numbers | AR-1650-02 |
Product
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Reason for recall
During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user.
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-0928-2017. 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.