Class II — Biorep Technologies
| Recalling firm | Biorep Technologies, Inc. |
|---|---|
| Registered facility | BIOREP TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component. |
| 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. |
| Quantity | 80 boxes (480 units) |
| Distribution | US Distribution to a distributor in MN. |
| Initiated | 2014-03-19 |
| Classified | 2014-05-02 |
| Terminated | 2014-08-07 |
| Recall number | Z-1538-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biorep Technologies (Z-1538-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68093/
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