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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

Pentax Medical Video Scopes and Processors Recalled for Thermal Injury Risk

Agency Publication Date: February 26, 2025
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Summary

Pentax of America Inc has recalled approximately 384 PENTAX Medical Video Scopes and Processors, including Colonoscopes (EC38-i20cL), Upper GI Scopes (EG29-i20c), and Video Processors (EPK-i8020c). During endoscopic procedures, the device tip can overheat, potentially causing smoke or steam and making the video image appear dark or reddish. This defect can lead to serious internal burns for patients undergoing procedures with these devices.

Risk

The light guide at the endoscope tip can become dangerously hot during or after use, which poses a significant risk of thermal injury to a patient's internal mucous membranes. Users have reported seeing smoke-like steam from the devices and observing that the tips are hot to the touch.

What You Should Do

  1. This recall affects PENTAX Medical Video Colonoscopes (EC38-i20cL), Video Upper GI Scopes (EG29-i20c), and Video Processors (EPK-i8020c).
  2. Identify your device by checking the model and serial numbers printed on the equipment labels. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Pentax of America Inc or your authorized distributor to arrange for a return, replacement, or necessary correction to the equipment.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: PENTAX Medical Video Colonoscope (EC38-i20cL)
Model / REF:
EC38-i20cL
Serial Numbers (152):
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
UDI:
04961333252169

Recall number: Z-1236-2025; Quantity: 152 units

Product: PENTAX Medical Video Upper GI Scope (EG29-i20c)
Model / REF:
EG29-i20c
Serial Numbers (138):
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
UDI:
04961333252145

Recall number: Z-1237-2025; Quantity: 138 units

Product: Pentax Medical Video Processor (EPK-i8020c)
Model / REF:
EPK-i8020c
Serial Numbers (94):
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
UDI:
04961333247974

Recall number: Z-1238-2025; Quantity: 94 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96164
Status: Active
Manufacturer: Pentax of America Inc
Sold By: PENTAX Medical; Authorized Medical Distributors
Manufactured In: United States
Units Affected: 3 products (152 units; 138 units; 94 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.