FDA Device recall Z-0031-2014
UNITRAC Pneumatic Retraction Arm
- FDA Device
- Class II
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class II recall of UNITRAC Pneumatic Retraction Arm by Aesculap, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0031-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-16 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | US |
Product
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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.
Identifiers
| code_info | RT040R, all lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Aesculap
- Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Descr…
FDA Device · Class II · 2026-03-11 · Aesculap - Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Desc…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description…
FDA Device · Class II · 2025-11-05 · Aesculap
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0031-2014%22
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