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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

Applied Medical Resources Corp: Epix Universal Clip Applier Recalled Due to Failure to Load Surgical Clips

Agency Publication Date: March 27, 2024
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Summary

Applied Medical Resources Corp has recalled 17,990 units of the Epix Universal Clip Applier (Model CA500), including those sold individually and within various surgical kits. The recall was initiated because the device may fail to load a surgical clip into its jaws after the trigger is pressed, which can interrupt surgical procedures. These medical devices were distributed nationwide in the United States and worldwide for use in laparoscopic and general surgeries. If you are a patient or healthcare provider, contact your medical facility or the manufacturer to determine if your specific device is affected.

Risk

The failure of the device to load a clip after trigger actuation can lead to delays in surgery while a replacement device is obtained, potentially increasing the time a patient is under anesthesia or causing complications during critical vessel ligation. While the risk of immediate injury is moderate, the mechanical failure of a primary surgical tool during an invasive procedure requires immediate attention.

What You Should Do

  1. Immediately identify if you have the Epix Universal Clip Applier (REF: CA500) or any of the listed surgical kits (such as GK1003, GK131, or K2922) by checking the Reference Number and Lot Number on the product packaging.
  2. Cross-reference your inventory against the extensive list of affected lot codes, including individual lot 1475580 through 1495845 and specific kit-based lots such as 1493930 or 1514524.
  3. If you are a healthcare provider, immediately stop using devices from the affected lots and quarantine them to prevent further use in surgical procedures.
  4. Contact your healthcare facility's risk management or procurement department to coordinate the return of the affected medical devices to Applied Medical Resources Corp.
  5. For further instructions, potential replacement, or to report issues, contact Applied Medical Resources Corp directly at their Rancho Santa Margarita headquarters at 949-713-8000 or visit their website.
  6. For additional questions or to report a related injury, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Epix Universal Clip Applier, REF: CA500, STERILEEO
Model / REF:
CA500
Lot Numbers (116):
1475580
1475581
1477351
1477352
1477353
1477354
1477355
1477356
1477357
1477358
1477359
1478016
1478017
1478018
1478019
1478089
1478155
1478925
1478926
1478927
1479771
1479772
1479773
1479774
1479969
1479971
1482641
1482644
1482645
1482646
1482647
1482648
1482649
1482954
1484000
1484004
1484005
1484021
1484022
1484023
1484024
1484025
1484026
1486035
1486036
1486037
1486038
1486039
1487790
1487791
Product: Epix Universal Clip Applier included within Surgical Kits
Model / REF (84):
GK1003
GK1004
GK1005
GK1011
GK1014
GK1018
GK1033
GK1044
GK1047
GK1063
GK1068
GK1071
GK1083
GK1094
GK1096
GK1101
GK131
GK153
GK168
GK258
GK260
GK307
GK308
GK320
GK358
GK360
GK363
GK364
GK365
GK368
GK401
GK402
GK736
GK738
GK739
GK834
GK835
GK837
GK857
GK858
GK861
GK874
GK877
GK878
GK879
GK891
GK895
GK905
GK920
GK921
Lot Numbers:
1493930
1499051
1505559
1509312
1510944
1498012
1498814
1507422
1510192
1503416
1492258
1505119
1509639
1512551
1514524

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94034
Status: Active
Manufacturer: Applied Medical Resources Corp
Sold By: Medical facilities; Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 17,990 units
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

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 · 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.