Aesculap Recalls UNITRAC Pneumatic Retraction Arms Due to Safety Instructions
Aesculap, Inc. is recalling 217 UNITRAC Pneumatic Retraction Arms because updated instructions for use are required to ensure safe operation and extend product life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a precautionary update to instructions for use to ensure safe operation and extend product life, without reporting any specific injuries, illnesses, or structural defects. This aligns with the rubric for voluntary precautionary recalls or minor labeling/instructional errors.
Plain-English summary
Aesculap, Inc. is recalling 217 units of the UNITRAC Pneumatic Retraction Arm, a support arm used to hold surgical instruments during surgical procedures. The recall involves code RT040R and all lot numbers, with nationwide distribution.
The recall was initiated to implement changes to the instructions for use. These changes are intended to ensure safe use and potentially extend the life of the product. The updated instructions recommend using the Sterile Cover JG901 and the new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC. Additionally, a functional check prior to use has been added to ensure optimal functionality of the UNITRAC system.
Healthcare facilities and users should stop using the affected units and contact Aesculap, Inc. for further instructions on how to obtain the updated instructions for use.
The recalled product
- Product
- UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
- Manufacturer
- Aesculap, Inc.
- Hazard
- Affected units
- 217
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- RT040R
- all lot numbers
Distribution
Distributed nationwide across the United States.
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