Aesculap proSA Adjustment Disc Recalled for Accuracy Out of Specification
Aesculap, Inc. is recalling 79 units of the proSA Adjustment Disc Size Large because the accuracy is out of specification.
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 does not report any hospitalizations, injuries, or illnesses, and the defect is a specification accuracy issue rather than a high-risk pathogen or structural failure.
Plain-English summary
Aesculap, Inc. is recalling 79 units of the Aesculap proSA Adjustment Disc Size Large (L). The recall is due to the accuracy of the device being out of specification. The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
The affected lots are 4505268906, 4505336973, 4505408485, and 4505238953. The product was distributed worldwide, including in the United States (AZ, MD, MA, WI, MI, MN, DE, KS, and FL) and in Australia, Germany, Great Britain, Norway, and Japan.
The source text does not specify any reported injuries, illnesses, or deaths associated with this recall. Consumers and healthcare providers should contact Aesculap, Inc. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
- Manufacturer
- Aesculap, Inc.
- Hazard
- Affected units
- 79
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 (4)
- 4 lots: 4505268906
- 4505336973
- 4505408485
- 4505238953
Distribution
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