Epix Universal Clip Applier, REF: CA500, STERILEEO recallZ-1388-2024 · Applied Medical Resources Corp · initiated Jan 30, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Applied Medical Resources Corp or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

FDA root cause category: Under Investigation by firm

What the company is doing

On February 16, 2024, Applied Medical issued a "Urgent: Medical Device Recall" notification to affected consignees via UPS. In addition, to informing consignees about the recall, Applied Medical asked consignees to take the following actions: " Check your inventory for recalled product. " Quarantine any product from the impacted lots above (Page 1) or kits listed below (Page 7-10). " Complete the attached Distributor Recall Notification Confirmation Form (Page 4) to acknowledge the recall and indicate if your facility is returning or has already used the lots listed above. o If no product is being returned, please indicate on the Distributor Recall Notification Confirmation Form (Page 4). o Please notify any facilities to which you distributed the affected product with a copy of this notification. Please also complete the Distributor Recall Notification Confirmation Report (Page 5). o For any product returned to your facility, please return the affected product to Applied Medical. " Return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to (949) 221-3639. " Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical (Product Return Instructions are on Page 6).

Recall details

Recall number: Z-1388-2024
Status: Open, Classified
Initiated by the company: Jan 30, 2024
Posted by the FDA: Mar 27, 2024
Recalling firm: Applied Medical Resources Corp
Product code: MDM
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Venezuela.

Product description

Epix Universal Clip Applier, REF: CA500, STERILEEO

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI: (01)00607915125318/Lot Codes: 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 1487792 1488875 1488876 1488877 1488878 1488910 1488967 1488968 1488969 1489421 1489531 1489532 1489874 1489895 1489896 1489897 1489898 1490284 1490315 1490523 1490524 1491058 1491059 1491060 1491910 1491914 1491916 1492220 1493194 1493195 1493196 1493197 1493198 1493420 1493421 1493422 1493423 1493568 1493569 1493590 1493591 1494324 1494470 1494471 1495262 1495263 1495270 1495807 1495808 1495809 1495830 1495831 1495832 1495833 1495834 1495835 1495836 1495837 1495838 1495839 1495840 1495841 1495842 1495843 1495844 1495845

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Epix® Universal Clip Applier CA500
Applied Medical Resources Corporation · Clip, Implantable
1 recall1 death1,183 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 94034).

Z-1389-2024 · Open, Classified
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - HPATE…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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