FDA Device recall Z-1236-2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower g…
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower g… by Pentax, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1236-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-29 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Pentax |
| Distribution | US |
Product
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
Reason
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.
Identifiers
| code_info | UDI: 04961333252169 Serial Numbers: A002FA0230 A002FA0244 A002FA0246 A002FA0247 A002FA0248 A002FA0259 A002FA0269 A002FA…UDI: 04961333252169 Serial Numbers: A002FA0230 A002FA0244 A002FA0246 A002FA0247 A002FA0248 A002FA0259 A002FA0269 A002FA0271 A002FA0272 A002FA0274 A002FA0275 A002FA0278 A002FA0281 A002FA0282 A002FA0283 A002FA0293 A002FA0294 A002FA0299 A002FA0300 A002FA0301 A002FA0303 A002FA0304 A002FA0306 A002FA0307 A002FA0311 A002FA0314 A002FA0315 A002FA0316 A002FA0321 A002FA0324 A002FA0364 A002FA0371 A002FA0372 A002FA0376 A002FA0378 A002FA0381 A002FA0383 A002FA0384 A002FA0388 A002FA0390 A002FA0399 A002FA0408 A002FA0415 A002FA0418 A002FA0419 A002FA0420 A002FA0422 A002FA0423 A002FA0424 A002FA0428 A002FA0432 A002FA0433 A002FA0435 A002FA0436 A002FA0437 A002FA0438 A002FA0439 A002FA0440 A002FA0443 A002FA0445 A002FA0446 A002FA0460 A002FA0462 A002FA0466 A002FA0474 A002FA0476 A002FA0477 A002FA0479 A002FA0485 A002FA0486 A002FA0487 A002FA0491 A002FA0492 A002FA0493 A002FA0496 A002FA0497 A002FA0505 A002FA0506 A002FA0514 A002FA0523 A002FA0539 A002FA0570 A002FA0578 A002FA0579 A002FA0580 A002FA0581 A002FA0592 A002FA0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1236-2025%22
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