Pentax of America Inc recalls
Every recall we track for Pentax of America Inc — 18 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Pentax of America Inc peaked in 2018 (6); 18 since 2017. 17% rated “stop using now”.
All FDA recall records for Pentax of America Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 1 | 1 |
| 2018 | 0 | 2 | 4 | 0 | 6 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 2 | 2 | 4 |
| 2021 | 1 | 0 | 2 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 2 | 2 | 0 | 0 | 4 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Pentax of America Inc recalls
What to do if you have a recalled Pentax of America Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Pentax of America Inc recalls
11 shown- Stop using nowMedical device
Pentax of America Inc recalls Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax recalls EPK-i8020c medical video processors after users reported reddish images and hot light guides causing potential mucous membrane burns during endoscopy.
PentaxJul 16, 2025 - Use cautionMedical device
Pentax of America Inc recalls Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral
Pentax recalls EPK-i8020c video processors used with endoscopes due to rare reddish image and potential thermal injury to patient mucous membranes during procedures.
PentaxJan 29, 2025 - Lower riskMedical device
Pentax of America Inc recalls Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K,
Pentax recalls certain gastroscopes made between April 2014 and May 2021 that lack a water jet channel, which could lead to improper cleaning and infection risks.
PentaxJul 14, 2021 - Stop using nowMedical device
Pentax of America Inc recalls Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary
Pentax recalls ED34-i10T2 duodenoscopes due to risk of distal end cap detaching during procedures, potentially causing mucosal injury or aspiration. Affected units may require immediate action.
PentaxApr 21, 2021 - Lower riskMedical device
Pentax of America Inc recalls 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Pentax recalls 9372HD Digital Capture systems with version 1.1.0+ where exam videos could be copied between patients during follow-up reviews. Affected units have specific computer serial numbers listed.
PentaxSep 22, 2020 - UnratedMedical device
Pentax of America Inc recalls Pentax Video Colonoscope Model: EC38-i10L
Pentax recalls EC38-i10L colonoscopes sold without FDA approval. Affected units lack required safety clearance. Consumers should contact manufacturer for details.
PentaxJan 3, 2020 - Use cautionMedical device
PENTAX of America Inc recalls C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is
Pentax recalls C2 CryoBalloon Controller software v1.18.258 due to potential balloon overpressure during nitrous oxide use, risking tissue injury. Affected units sold with specific reference numbers.
PentaxDec 3, 2018 - Lower riskMedical device
PENTAX of America Inc recalls Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon
Pentax recalls specific models of cryosurgical catheters due to potential incorrect dose transmission to the controller, which could affect treatment safety. Affected units include certain lot numbers from 2018.
PentaxDec 3, 2018 - Use cautionMedical device
PENTAX of America Inc recalls C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field
Pentax recalls C2 CryoBalloon Focal Catheter (REF FG-1009) due to potential detachment from controller during surgery. Affected units have specific lot codes.
PentaxMar 30, 2018 - Lower riskMedical device
Pentax of America Inc recalls Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are
Pentax recalls ED-3490TK duodenoscopes due to potential infection risk from outdated design. Replace with updated model per manufacturer instructions.
PentaxFeb 13, 2018 - UnratedMedical device
Pentax of America Inc recalls Video Cystoscope models ECY-1570 and ECY-1570K
Pentax recalls video cystoscope models ECY-1570 and ECY-1570K due to lack of FDA 510(k) premarket clearance. Affected units have specific serial numbers listed in the recall notice.
PentaxJul 13, 2017
Pentax of America Inc recall questions
How many recalls has Pentax of America Inc had?
18 recalls from Pentax of America Inc are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Pentax of America Inc recall?
Pentax of America Inc recalls Pentax Medical Video Processor; Model Number: EPK-i8020c;, dated Jul 16, 2025. Every Pentax of America Inc recall is listed on this page, newest first.
Why are Pentax of America Inc products recalled?
The most common reasons on record: Distributed in the USA without an approved 510K (2).
What should I do if I have a recalled Pentax of America Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Pentax of America Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.