Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of…
Medical device recall Z-2513-2023. Published in FDA’s Enforcement Report on Sep 13, 2023.
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 Sep 13, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 15,951 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?
Sterility of device may be compromised due to breach of the chevron seal of the packaging
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
15,951, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Device Identifier (DI): (01)00827002200036(17) Lot Numbers: N172707 N172737 N172738 N172875 N172887 N172912 N173153 N173178 N173180 N173434 N173519 N173623 N173653 N173688 N173690 N173691 N173879 N173943 N173959 N173976 N173977 N174034…
Every code shown here, 1,996 characters
Device Identifier (DI): (01)00827002200036(17) Lot Numbers: N172707 N172737 N172738 N172875 N172887 N172912 N173153 N173178 N173180 N173434 N173519 N173623 N173653 N173688 N173690 N173691 N173879 N173943 N173959 N173976 N173977 N174034 N174104 N174134 N174169 N174170 N174287 N174294 N174466 N174535 N174536 N174564 N174589 N174704 N174778 N174841 N174863 N174864 N174889 N174906 N175146 N175201 N175247 N175277 N175589 N175627 N175963 N175964 N175987 N176084 N176262 N176322 N176323 N176712 N176714 N176715 N176716 N176829 N176830 N176974 N177094 N177101 N177102 N177217 N177218 N177239 N177351 N177496 N177515 N177678 N177682 N177797 N177853 N177898 N177927 N178015 N178054 N178093 N178224 N178225 N178276 N178340 N178518 N178562 N178609 N178633 N178675 N178676 N178677 N178764 N178784 N178813 N178814 N179019 N179021 N179130 N179209 N179211 N179301 N179302 N179333 N179361 N179396 N179397 N179503 N179504 N179534 N179728 N179874 N179903 N180036 N180038 N180077 N180115 N180116 N180147 N180313 N180314 N180370 N180371 N180458 N180459 N180504 N180768 N180769 N180953 N181027 N181056 N181127 N181397 N181437 N181438 N181530 N181581 N181582 N181626 N181628 N181629 N181801 N181804 N182095 N182137 N182282 N182524 N182552 N182691 N182817 N182824 N182943 N182945 N183030 N183042 N183043 N183119 N183120 N183261 N183262 N183263 N183457 N183533 N183535 N183737 N183738 N183826 N183841 N183857 N183939 N184187 N184188 N184222 N184319 N184320 N184409 N184517 N184518 N184580 N184612 N184735 N184736 N184880 N184881 N184989 N184990 N185156 N185238 N185239 N185271 N185334 N185335 N185570 N185579 N185612 N185613 N185615 N185879 N185880 N186216 N186317 N186318 N186541 N186581 N186683 N186684 N186748 N186749 N186780 N186835 N186837 N186887 N186888 N186963 N186999 N187000 N187048 N187049 N187107 N187213 N187246 N187300 N187301 N187302 N187317 N187338 N187359 N187436 N187438 N187519 N187522 N187727 N187728 N187776 N187777 N187811 N187841 N188171 N188172 N188238 N188239 N188290 N188322 N188323 N188347…
FDA’s list runs to 2,924 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 distribution - US Nationwide including PR and the countries of AE, AT, AU, BE, BN, BY, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GT, HK, HU, IE, IL (EUDC), IL (NADC), IT, JP, KW, MX, NL, NO, PL, PR, PT, SE, TH, TR, UY, ZA.
The states and territories these words name
- Puerto Rico
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 Jul 24, 2023.
- FDA classified it on Sep 1, 2023.
- FDA’s Enforcement Report published it on Sep 13, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Vandergrift, Inc., of Vandergrift, PA.
- 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 2,924 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.