UNITRAC Pneumatic Retraction Arm — Class II medical device recall Z-0031-2014
Terminated recall by Aesculap, Inc., reported 2013-10-30, distributed nationwide. Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the lif
| Recall number | Z-0031-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2013-07-16 |
| Classified | 2013-10-21 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 217 |
| Reason classes | sterility |
Product
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Reason for recall
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.
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-0031-2014. 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.