Epix Universal Clip Applier
Medical device recall Z-1389-2024. Published in FDA’s Enforcement Report on Apr 3, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 3, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- 17,990 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON’S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002
17,990 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Reference Number/Lot Number/UDI Number: GK1003, AME KIT 54562 1493930 (01)20607915144979(17)250911(30)01(10)1493930 GK1003, AME KIT 54562 1499051 (01)20607915144979(17)251030(30)01(10)1499051 GK1003, AME KIT 54562 1505559…
Every code shown here, 1,998 characters
Reference Number/Lot Number/UDI Number: GK1003, AME KIT 54562 1493930 (01)20607915144979(17)250911(30)01(10)1493930 GK1003, AME KIT 54562 1499051 (01)20607915144979(17)251030(30)01(10)1499051 GK1003, AME KIT 54562 1505559 (01)20607915144979(17)251030(30)01(10)1505559 GK1003, AME KIT 54562 1509312 (01)20607915144979(17)260116(30)01(10)1509312 GK1003, AME KIT 54562 1510944 (01)20607915144979(17)260327(30)01(10)1510944 GK1004, KIT LAP CHOL DEN HOED 2 1498012 (01)20607915144993(17)251106(30)01(10)1498012 GK1004, KIT LAP CHOL DEN HOED 2 1498814 (01)20607915144993(17)251106(30)01(10)1498814 GK1004, KIT LAP CHOL DEN HOED 2 1507422 (01)20607915144993(17)250420(30)01(10)1507422 GK1004, KIT LAP CHOL DEN HOED 2 1510192 (01)20607915144993(17)260403(30)01(10)1510192 GK1005, K2550 - H¿PATECTOMIE ERASME 1503416 (01)20607915145006(17)251102(30)01(10)1503416 GK1011, K-19459 1492258 (01)20607915145136(17)240908(30)01(10)1492258 GK1011, K-19459 1494291 (01)20607915145136(17)240908(30)01(10)1494291 GK1011, K-19459 1496830 (01)20607915145136(17)240908(30)01(10)1496830 GK1011, K-19459 1501491 (01)20607915145136(17)240908(30)01(10)1501491 GK1011, K-19459 1503409 (01)20607915145136(17)241110(30)01(10)1503409 GK1011, K-19459 1505119 (01)20607915145136(17)241003(30)01(10)1505119 GK1011, K-19459 1506824 (01)20607915145136(17)250804(30)01(10)1506824 GK1011, K-19459 1509999 (01)20607915145136(17)250804(30)01(10)1509999 GK1011, K-19459 1512086 (01)20607915145136(17)260202(30)01(10)1512086 GK1014, K-18031 STANDARD KIT 1492615 (01)20607915145112(17)250821(30)01(10)1492615 GK1014, K-18031 STANDARD KIT 1498019 (01)20607915145112(17)251106(30)01(10)1498019 GK1014, K-18031 STANDARD KIT 1500346 (01)20607915145112(17)260205(30)01(10)1500346 GK1018, K-20735 STANDARD KIT 1490830 (01)20607915145211(17)250821(30)01(10)1490830 GK1018, K-20735 STANDARD KIT 1493458 (01)20607915145211(17)250307(30)01(10)1493458 GK1018, K-20735 STANDARD KIT 1493663 (01)20607915145211(17)250911(30)01(10)1493663 GK1018, K-20735…
FDA’s list runs to 46,880 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
48 states and territories.
Every one of them
- 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
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 30, 2024.
- FDA classified it on Mar 27, 2024.
- FDA’s Enforcement Report published it on Apr 3, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Applied Medical Resources Corp, of Rancho Santa Margarita, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 46,880 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.