Joseph Lamelas Atrial Lift System — Class II medical device recall Z-1538-2014
Terminated recall by Biorep Technologies, reported 2014-05-14, distributed in MN. The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the
| Recall number | Z-1538-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biorep Technologies, Miami, FL, United States |
| Recall initiated | 2014-03-19 |
| Classified | 2014-05-02 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-08-07 |
| Distributed | MN |
| Reason classes | device malfunction |
| Lot numbers | 166934413 |
| Model numbers | MI-ALS-001 |
Product
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Reason for recall
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
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-1538-2014. 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.