Bodor P and C series laser cutting machines recalled for non-compliance
Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This medical device recall involves laser equipment that does not comply with FDA safety standards. Laser equipment poses inherent risk of harm through burns and eye damage. No injuries have been reported, but the non-compliance of a risk-of-harm product with FDA standards justifies a high severity rating.
Plain-English summary
The manufacturer, Jinan Bodor Cnc Machine Co Ltd, is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide in the United States. The affected models include P series (model 2421537-000) and C series (model 2421612-000). These machines are non-compliant with FDA medical device standards.
Laser cutting machines that do not comply with FDA safety standards may present hazards to users. Affected consumers should immediately stop using these machines and contact the manufacturer for recall instructions.
The recalled product
- Product
- Bodor P and C series laser cutting machines
- Manufacturer
- Jinan Bodor Cnc Machine Co Ltd
- Category
- Medical Device — Laser Equipment
- Hazard
- Affected units
- 269
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 (1)
- P series is 2421537-000 and C series is 2421612-000.
Distribution
Distributed nationwide across the United States.
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