Hearth Record

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier

Medical device recall Z-0497-2020. Published in FDA’s Enforcement Report on Nov 27, 2019.

FDA’s own record, on accessdata.fda.gov

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 Nov 27, 2019. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

4099 devices, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Codes: 73J1600836 73C1700518 73D1800018 73H1800233 73A1900664 73J1600837 73C1700842 73D1800019 73H1800234 73B1900436 73K1600114 73D1700008 73D1800020 73H1800235 73B1900437 73K1600115 73D1700009 73D1800558 73H1800236 73B1900438 73K1600290…

Every code shown here, 1,998 characters

Codes: 73J1600836 73C1700518 73D1800018 73H1800233 73A1900664 73J1600837 73C1700842 73D1800019 73H1800234 73B1900436 73K1600114 73D1700008 73D1800020 73H1800235 73B1900437 73K1600115 73D1700009 73D1800558 73H1800236 73B1900438 73K1600290 73D1700010 73D1800559 73H1800240 73K1600515 73D1700068 73D1800560 73H1800496 73K1600814 73D1700069 73D1800561 73H1800497 73L1600097 73D1700313 73D1800562 73H1800498 73L1600098 73D1700314 73D1800563 73H1800499 73L1600099 73D1700315 73D1800564 73H1800500 73L1600100 73D1700496 73D1800565 73H1800501 73L1600101 73D1700497 73E1800526 73H1800502 73L1600274 73D1700574 73E1800527 73H1800639 73L1600275 73D1700575 73E1800528 73H1800640 73L1600276 73F1700209 73E1800529 73H1800641 73L1600277 73F1700210 73E1800530 73H1800642 73L1600278 73G1700345 73F1800263 73H1800643 73L1600279 73G1700346 73F1800264 73H1800820 73L1600280 73G1700347 73F1800265 73J1800298 73L1600540 73G1700720 73F1800266 73J1800299 73L1600792 73G1700721 73F1800267 73J1800300 73L1600793 73H1700095 73F1800268 73J1800301 73L1600794 73H1700096 73F1800269 73J1800302 73L1600795 73H1700097 73F1800270 73J1800303 73L1600796 73H1700098 73F1800486 73J1800304 73L1600797 73B1800105 73F1800487 73J1800305 73L1600798 73B1800106 73F1800759 73J1800306 73M1600217 73B1800188 73F1800760 73J1800718 73M1600218 73B1800189 73F1800761 73J1800719 73M1600219 73B1800190 73G1800089 73J1800720 73M1600220 73B1800192 73G1800520 73K1800055 73M1600281 73B1800216 73G1800521 73K1800057 73M1600282 73B1800217 73G1800522 73K1800058 73A1700205 73C1800125 73G1800525 73K1800691 73A1700206 73C1800126 73G1800726 73K1800694 73A1700207 73C1800127 73G1800727 73K1800700 73A1700348 73C1800128 73G1800728 73K1800701 73A1700349 73C1800129 73G1800729 73K1800702 73B1700226 73C1800130 73G1800730 73K1800703 73B1700276 73C1800131 73G1800731 73M1800021 73B1700486 73C1800132 73G1800877 73M1800022 73B1700487 73D1800013 73G1800878 73M1800023 73C1700335 73D1800014 73H1800138 73M1800024 73C1700360 73D1800015 73H1800139 73M1800025 73C1700361…

FDA’s list runs to 2,074 characters. The first part is shown; the rest is on FDA’s record.

Source:

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, including US nationwide (including Puerto Rico).

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.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Oct 4, 2019.
  • FDA classified it on Nov 19, 2019.
  • FDA’s Enforcement Report published it on Nov 27, 2019.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Teleflex Medical, of Morrisville, NC.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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 2,074 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

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An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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