Pentax Medical Recalls Video Duodenoscopes Due to CRE Infection Reports
Pentax Medical is recalling 423 Video Duodenoscopes nationwide after reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device associated with reports of a serious, drug-resistant infection (CRE), which aligns with the rubric criterion for 'significant injury' or high-risk pathogen exposure in a medical context, warranting a Severe classification.
Plain-English summary
Pentax Medical Company is recalling 423 units of its Video Duodenoscope products. The recall is being conducted nationwide. The specific serial numbers affected are listed in the agency's structured data, ranging from A110021 to H110894.
The recall was initiated after Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility. The source text does not specify the number of patients affected, the specific facility, or the dates of the infections.
Healthcare facilities and consumers should check their inventory of Video Duodenoscopes against the provided serial number list. If a device is affected, it should be removed from service and returned to Pentax Medical or the appropriate regulatory authority as directed.
The recalled product
- Product
- Video Duodenoscope
- Manufacturer
- Pentax Medical Company
- Category
- Medical Device — Endoscopy
- Affected units
- 423
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 (20)
- A110021
- A110022
- A110023
- A110024
- A110025
- A110026
- A110027
- A110028
- A110029
- A110030
- A110031
- A110032
- A110033
- A110034
- A110035
- A110036
- A110037
- A110038
- A110039
- A110043
Distribution
Distributed nationwide across the United States.
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