Brainlab DrapeLink Adapter Recall Due to Manufacturing Error
Brainlab AG is recalling DrapeLink Adapters because a supplier error caused some units to not meet specifications.
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. The source text does not report any illnesses, injuries, or deaths, and the hazard is a manufacturing deviation without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Brainlab AG is recalling 80 Brainlab DrapeLink Registration Kit Adapter Left devices. The recall is due to a human error at a supplier that resulted in an unknown number of devices within one specific production lot not being manufactured according to defined specifications.
The affected devices are part of the Brainlab Navigation System Spine & Trauma 3D. The specific components involved are the Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left. The devices were distributed in the United States to Kansas and internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom.
Healthcare facilities should stop using the affected devices and contact Brainlab AG for instructions on how to return or replace them. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
- Manufacturer
- Brainlab AG
- Hazard
- Affected units
- 80
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)
- Model No. 19154
- UDI GTIN 04056481132187. Model No. 19154-04
Distribution
Distributed in 1 state:
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