Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and…
Medical device recall Z-1621-2016. Published in FDA’s Enforcement Report on May 18, 2016.
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 May 18, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 44 states named in where it went
- 559,274 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?
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
559,274, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CA090 Direct Drive Clip Applier Lots: 1190181 to 1265006 Kit Lots (containing CA090 Direct Drive Clip Applier recalled lot(s)): 1247881 1252438 1255011 1257686 1261514 1263870 1265289 1248696 1254259 1262161 1262467 1241744 1242506 1241942…
Every code shown here, 2,000 characters
CA090 Direct Drive Clip Applier Lots: 1190181 to 1265006 Kit Lots (containing CA090 Direct Drive Clip Applier recalled lot(s)): 1247881 1252438 1255011 1257686 1261514 1263870 1265289 1248696 1254259 1262161 1262467 1241744 1242506 1241942 1242530 1244945 1246374 1247757 1248255 1248753 1251538 1254642 1256360 1265424 1266435 1241831 1242149 1242700 1244651 1244720 1244857 1246492 1246909 1247486 1248756 1251861 1257536 1258435 1261116 1266358 1243272 1234619 1235710 1237695 1238548 1238846 1240793 1244468 1246491 1247651 1247655 1248775 1250498 1250581 1255478 1257218 1258823 1262556 1264157 1238840 1242936 1245022 1245534 1248456 1251192 1252437 1252548 1230056 1235603 1234727 1235922 1237439 1238326 1238403 1238545 1238839 1239478 1240334 1225992 1233274 1235045 1235785 1235914 1237299 1238555 1240591 1249603 1251343 1253126 1255634 1257818 1260397 1263662 1225996 1237442 1237866 1238404 1238477 1238547 1239373 1239475 1239693 1239787 1240084 1252145 1255075 1255630 1256446 1257220 1258017 1258726 1260294 1261907 1263948 1226411 1236219 1241391 1242529 1243974 1244946 1248224 1226407 1235931 1237674 1242254 1243047 1243791 1243891 1249850 1256895 1259667 1259851 1219268 1221879 1225510 1227601 1231153 1232472 1234612 1235932 1237776 1237685 1237613 1241065 1243412 1248933 1252254 1258822 1262980 1263752 1221402 1224448 1225688 1228275 1229519 1231540 1233085 1237208 1208179 1212899 1218330 1220676 1224025 1226700 1228640 1231752 1235420 1235933 1237446 1238957 1244715 1248930 1260050 1262974 1207582 1211964 1213348 1215655 1220773 1224677 1225541 1229358 1229814 1232136 1235934 1237296 1237441 1238664 1241637 1245210 1249328 1250670 1252542 1255884 1258623 1208188 1214348 1215395 1217487 1220675 1222617 1224446 1225988 1229518 1232390 1237297 1202209 1219277 1220672 1222920 1228476 1231546 1234608 1235936 1236369 1237554 1237672 1240275 1244243 1246668 1248037 1250377 1250501 1254776 1255888 1258022 1259190 1200914 1206845 1209215 1212044 1214049 1216162 1218416…
FDA’s list runs to 4,119 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.
U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia
The states and territories these words name
44 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Apr 1, 2016.
- FDA classified it on May 6, 2016.
- FDA’s Enforcement Report published it on May 18, 2016.
- FDA terminated it on Feb 7, 2017.
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: Letter.
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 4,119 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
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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.