Robotic Drill Recall: Users Unable to Resolve Disconnection Errors
Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves inability to resolve drill disconnection error messages, which is a software functionality issue rather than a direct safety hazard. Per the rubric, Class II recalls without reported harm are scored as Moderate.
Plain-English summary
Blue Belt Technologies, Inc. is recalling the CORI REAL INTELLIGENCE Robotic Drill (Product No. ROB10013 and ROB10013S) due to a reported issue with error message resolution. The recall affects approximately 1,859 units distributed nationwide.
The FDA determined that users may be unable to resolve drill disconnection error messages. This was classified as a Class II recall. To date, no illnesses or injuries have been reported related to this issue.
The recalled product
- Product
- CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
- Manufacturer
- Blue Belt Technologies, Inc
- Category
- Medical Device
- Affected units
- 1,859
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 (3)
- UDI-DI: 00885556757321 and 00885556780886
- Serial No. SN00001 through SN001202
- SN500001 through SN502583.
Distribution
Distributed nationwide across the United States.
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