Pentax Medical Colonoscopes and Upper GI Scopes Updated Reprocessing Instructions
Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.
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: FDA classified this as a Class II medical device recall affecting reprocessing procedures for diagnostic endoscopes. While no illnesses or injuries are reported, the product poses risk of harm, as improper reprocessing of endoscopic instruments can compromise patient safety. This aligns with the High severity criterion for risk-of-harm medical devices without reported injury.
Plain-English summary
Pentax of America has issued an updated reprocessing instruction for use (rIFU) affecting multiple models of their Video Colonoscopes (EC Family) and Upper GI Scopes (EG Family) used for diagnostic procedures. Approximately 28,849 units were distributed nationwide between April 2014 and May 2021.
The update addresses reprocessing procedures for these endoscopic devices after clinical use. Healthcare facilities using affected Pentax models should implement the updated reprocessing instructions provided by the manufacturer.
Patients who have undergone procedures at healthcare facilities using affected Pentax colonoscope or Upper GI scope models during the distribution period should consult their healthcare provider if they have concerns about the devices used in their care.
The recalled product
- Product
- Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with…
- Manufacturer
- Pentax of America Inc
- Affected units
- 28,849
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)
- All devices distributed by Pentax in the US between April 2014 and May 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pentax of America Inc 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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