Pentax Video Bronchoscopes Recalled for Incorrect Operation and Reprocessing Instructions
Pentax of America Inc. is recalling 1,719 video bronchoscopes because they contain an incorrect Operation and Reprocessing IFUS.
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 identifies the issue as an incorrect Instruction for Use (documentation) rather than a physical defect causing injury, aligning with the 'Moderate' criteria for minor labeling or documentation issues.
Plain-English summary
Pentax of America Inc. is recalling 1,719 units of Pentax Video Bronchoscopes. These devices are designed for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. The recall covers specific models including EB-1170K, EB-1570K, EB-1575K, EB-1970K, EB-1970TK, and EB-1975K.
The reason for the recall is that the devices contain an incorrect Operation and Reprocessing IFUS (Instructions for Use). The agency has classified this as a Class II recall. The products were distributed nationwide.
Healthcare facilities and users should stop using the affected bronchoscopes and contact Pentax of America Inc. for further instructions regarding the replacement or correction of the documentation.
The recalled product
- Product
- Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 1,719
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 (6)
- EB-1170K
- EB-1570K
- EB-1575K
- EB=1970K
- EB-1970TK
- EB-1975K
Distribution
Distributed nationwide across the United States.
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