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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus OFP-2 Flushing Pumps Recalled for Potential Loss of Function

Agency Publication Date: October 25, 2024
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Summary

Olympus Corporation of the Americas is recalling 445 units of its OFP-2 Endoscopic Flushing Pump (Model/Catalog Number: OFP-2, K10001141). This recall was initiated after product testing revealed an internal component connection failure that causes the pump to stop working intermittently. If the device loses function during a surgical or diagnostic procedure, it could lead to procedural delays or complications for the patient.

Risk

The flushing pump may experience an intermittent loss of function due to a failure in its internal connections. This defect could cause the device to stop working unexpectedly during a medical procedure, though no injuries or incidents have been reported to date.

What You Should Do

  1. This recall affects Olympus Endoscopic Flushing Pumps, Model/Catalog Number OFP-2 (K10001141), with UDI-DI 15019778003191.
  2. Identify if your device is affected by checking the serial number printed on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Olympus Corporation of the Americas or your authorized medical distributor to arrange for a return, replacement, or correction of the pump.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions 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: Olympus Endoscopic Flushing Pump
Model / REF:
OFP-2 (K10001141)
Serial Numbers (445):
22324681
22324838
22324815
22324817
22324668
22324816
22324667
22324666
22324837
22325205
22325319
22325320
22325005
22324922
22325318
22325008
22324932
22325207
22324931
22325306
22325593
22325317
22325208
22325315
22325316
22325409
22325411
22325305
22325304
22325408
22325410
22324923
22325303
22325592
22325579
22326433
22325665
22326420
22326435
22326299
22325582
22325594
22326281
22324536
22326418
22326419
22325580
22325595
22325651
22326417
UDI:
15019778003191

Units affected: 445 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95440
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus Corporation of the Americas; authorized medical distributors
Manufactured In: United States
Units Affected: 445 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.