Class II — Aesculap, Inc.
| Recalling firm | AESCULAP, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system. |
| Product | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures. |
| Quantity | 217 |
| Distribution | Nationwide Distribution. |
| Initiated | 2013-07-16 |
| Classified | 2013-10-21 |
| Terminated | 2014-08-26 |
| Recall number | Z-0031-2014 |
| 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 — Aesculap, Inc. (Z-0031-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65952/
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