Pentax Cystoscopes Recalled Due to Risk of Lodged Accessories in Instrument Channel
Pentax Medical Company is recalling 120 cystoscopes because operational and therapeutic 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 medical device with a mechanical defect that could impede therapeutic procedures. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class II without hospitalization reports.
Plain-English summary
Pentax Medical Company is recalling 120 units of cystoscopes, including models ECY-1530, ECY-1570K, FCY-15P2, and FCY-15RBS. These devices are intended to provide optical visualization and therapeutic access to the urinary tract in adult and pediatric patients. The recall covers units distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam.
The recall was initiated because Pentax has become aware that 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 affects the specific models listed in the recall notice.
Healthcare providers and facilities should stop using the affected cystoscopes and contact Pentax Medical Company for further instructions on the recall process. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications…
- Manufacturer
- Pentax Medical Company
- Category
- Medical Device — Endoscopes
- Affected units
- 120
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)
- Model #'s ECY-1530
- ECY-1570K
- FCY-15P2 and FCY-15RBS
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.
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