CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report
Pentax Medical Video Processor- Intended to be used recalled
Pentax of America is recalling Pentax Medical Video Processor- Intended to be used with Pentax Medical endoscopes, distributed nationwide in the US. The recall was initiated on 29 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1238-2025
- FDA event ID
- 96164
- Recalling firm
- Pentax of America, Montvale, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2025
- FDA classified
- 26 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 29 Jan 2025 | Recall initiated by company | |
| 26 Feb 2025 | Classified by FDA | +28 days |
| 5 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Product as listed by the FDA
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Which lots are affected?
UDI: 04961333247974 Serial Numbers: B0023Z1193 B0023Z1195 B0023Z1245 B0023Z1247 B0023Z1250 B0023Z1255 B0023Z1256 B0023Z1276 B0023Z1277 B0023Z1279 B0023Z1280 B0023Z1286 B0023Z1290 B0023Z1296 B0023Z1313 B0023Z1335 B0023Z1451 B0023Z1461 B0023Z1478 B0023Z1481 B0023Z1565 B0023Z1573 B0023Z1628 B0023Z1631 B0023Z1637 B0023Z1639 B0023Z1645 B0023Z1648 B0023Z1652 B0023Z1653 B0023Z1655 B0023Z1656 B0023Z1659 B0023Z1661 B0023Z1665 B0023Z1667 B0023Z1669 B0023Z1671 B0023Z1676 B0023Z1678 B0023Z1682 B0023Z1694 B0023Z1696 B0023Z1698 B0023Z1711 B0023Z1712 B0023Z1716 B0023Z1717 B0023Z1732 C0023Z0021 C0023Z0072 C0023Z0074 C0023Z0078 C0023Z0082 C0023Z0084 C0023Z0085 C0023Z0087 C0023Z0091 C0023Z0092 C0023Z0094 C0023Z0095 C0023Z0096 C0023Z0097 D0023Z0011 D0023Z0017 D0023Z0108 D0023Z0109 D0023Z0112 D0023Z0117 D0023Z0118 D0023Z0119 D0023Z0122 D0023Z0123 D0023Z0125 D0023Z0140 D0023Z0142 D0023Z0222 D0023Z0241 D0023Z0248 D0158Z0019 D0158Z0033 D0158Z0049 D0158Z0053 E0023Z0002 E0023Z0004 E0023Z0007 E0023Z0008 E0023Z0009 E0023Z0013 E0023Z0016 E0023Z0018 E0023Z0020 E0023Z0024 E0023Z0026
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96164| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pentax Medical Video Upper GI Scope-Intended to provide recalled | Pentax of America | Other | Nationwide | |
| CLASS II | Pentax Medical Video Colonoscope- Intended to provide recalled | Pentax of America | Other | Nationwide |
More recalls from Pentax of America
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pentax Medical Video Processor recalled by Pentax of America | Pentax of America | Other | 20 states |
| Device | CLASS II | Pentax Medical Video Colonoscope- Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Pentax Medical Video Upper GI Scope-Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Colonoscope Family # 1-Pentax Video Colonoscopes recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel recalled | Pentax of America | Other | Nationwide |
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| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |