Pentax Medical Recalls Esophagoscopes Due to Lodged Accessories Risk
Pentax Medical is recalling 405 esophagoscopes because operational accessories can become lodged in the instrument channel.
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: The recall involves a risk-of-harm medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Pentax Medical Company is recalling 405 units of Esophagoscopes, specifically models EE-1540 and EE-1580k. These medical devices are used to examine the gastrointestinal tract, including the esophagus, stomach, and duodenum, in adult and pediatric patients.
The recall was initiated because operational and cleaning accessories, as well as therapeutic devices such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel. This issue poses a risk to patient safety during procedures.
The affected units were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam. Healthcare providers and consumers should stop using the affected devices and contact Pentax Medical Company for further instructions on the recall.
The recalled product
- Product
- Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult…
- Manufacturer
- Pentax Medical Company
- Category
- Medical Device — Endoscopes
- Hazard
- Affected units
- 405
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)
- Model #'s EE-1540 and EE-1580k
Distribution
Part of a larger recall action
This product is one of 16 recalled by Pentax Medical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
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