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Epix Universal Clip Applier, REF: CA500, STERILEEO

FDA Device Recall #Z-1388-2024 — Class II — January 30, 2024

Recall Summary

Recall Number Z-1388-2024
Classification Class II — Moderate risk
Date Initiated January 30, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Applied Medical Resources Corp
Location Rancho Santa Margarita, CA
Product Type Devices
Quantity N/A

Product Description

Epix Universal Clip Applier, REF: CA500, STERILEEO

Reason for Recall

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

Distribution Pattern

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.

Lot / Code Information

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

Other Recalls from Applied Medical Resources Corp

Recall # Classification Product Date
Z-1010-2026 Class II Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55... Dec 11, 2025
Z-1389-2024 Class II Epix Universal Clip Applier, REF: CA500, STERIL... Jan 30, 2024
Z-2160-2020 Class II DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)3... Mar 17, 2020
Z-2161-2020 Class II Clip Applier Kit, REF: K2887, UDI: (01)30607915... Mar 17, 2020
Z-2158-2020 Class II Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qt... Mar 17, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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