FDA Device recall Z-1237-2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower…
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower… 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-1237-2025 |
| 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 Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
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: 04961333252145 Serial Numbers: A0038A0431 A0038A0433 A0038A0435 A0038A0447 A0038A0451 A0038A0452 A0038A0454 A0038A…UDI: 04961333252145 Serial Numbers: A0038A0431 A0038A0433 A0038A0435 A0038A0447 A0038A0451 A0038A0452 A0038A0454 A0038A0458 A0038A0460 A0038A0474 A0038A0475 A0038A0479 A0038A0486 A0038A0488 A0038A0489 A0038A0492 A0038A0494 A0038A0496 A0038A0497 A0038A0500 A0038A0502 A0038A0503 A0038A0507 A0038A0513 A0038A0514 A0038A0516 A0038A0527 A0038A0529 A0038A0536 A0038A0538 A0038A0539 A0038A0541 A0038A0557 A0038A0558 A0038A0560 A0038A0563 A0038A0566 A0038A0568 A0038A0570 A0038A0573 A0038A0574 A0038A0575 A0038A0577 A0038A0579 A0038A0583 A0038A0584 A0038A0585 A0038A0594 A0038A0595 A0038A0596 A0038A0597 A0038A0598 A0038A0599 A0038A0600 A0038A0601 A0038A0602 A0038A0605 A0038A0606 A0038A0607 A0038A0608 A0038A0609 A0038A0610 A0038A0613 A0038A0615 A0038A0616 A0038A0617 A0038A0618 A0038A0619 A0038A0621 A0038A0622 A0038A0623 A0038A0624 A0038A0625 A0038A0630 A0038A0636 A0038A0638 A0038A0639 A0038A0640 A0038A0644 A0038A0645 A0038A0646 A0038A0647 A0038A0648 A0038A0654 A0038A0762 A0038A0786 A0038A0794 A0038AA |
|---|
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-1237-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.