Hearth Record

PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267

Medical device recall Z-0646-2015. Published in FDA’s Enforcement Report on Dec 24, 2014.

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 Dec 24, 2014. 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?

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

Source:

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

Which ones are recalled?

PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

180,573 units, in FDA’s words.

Source:

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

Codes to check against yours

44278 44400 140839 140841 142634 143161 144272 246221 246222 246706 246708 344732 440763 444744 444746 444747 444753 543666 543670 543676 642008 642014 642016 642021 642022 642023 647516 741834 741835 741839 741841 741842 741845 741850…

Every code shown here, 1,992 characters

44278 44400 140839 140841 142634 143161 144272 246221 246222 246706 246708 344732 440763 444744 444746 444747 444753 543666 543670 543676 642008 642014 642016 642021 642022 642023 647516 741834 741835 741839 741841 741842 741845 741850 742157 745055 745327 745636 746335 746336 746337 746338 746341 746348 746349 746352 746354 746979 844131 844181 844182 844184 844186 844192 844193 844196 844197 844198 844199 844201 844202 844305 844306 845990 845991 845992 845993 845995 845998 845999 846000 846001 846003 846004 846005 846006 846007 846008 846009 846010 846011 846012 846013 846014 864008 940460 940913 0943926E 0943927E 0943990E 0943991E 0943992E 0943993E 0943994E 0943995E 0943997E 0943999E 0944000E 0944001E 0944002E 0944003E 0944004E 0944006E 0944007E 0944008E 0944009E 0944010E 0944011E 0944013E 0944015E 0944016E 0944019E 0944021E 0944023E 0944025E 0944028E 0944031E 0944033E 0944035E 0944038E 0944040E 0944042E 0944044E 0944046E 0944048E 0944299E 0944669E 0944670E 0944671E 0945127E 0945213E 1022230 1042241E 1042476E 1042635E 1045242E 1045243E 1046071E 1046072E 1046074E 1046173E 1046198E 1046610E 1046849E 1046850E 1046851E 1046852E 1046853E 1046854E 1140198E 1140200E 1140201E 1141148E 1141149E 1141150E 1141609E 1142175E 1142176E 1142177E 1142178E 1142633E 1142634E 1142635E 1143088E 1143089E 1143090E 1143091E 1143452E 1143453E 1143454E 1143455E 1143456E 1143458E 1143653E 1144698E 1144699E 1144700E 1144701E 1144702E 1144703E 1144704E 1145290E 1145291E 1145292E 1145293E 1145828E 1145829E 1145830E 1145880E 1145881E 1145882E 1146384E 1146385E 1146386E 1146387E 1146573E 1146574E 1146696E 1146697E 1146698E 1147159E 1147160E 1240191E 1240192E 1240193E 1240194E 1240439E 1240440E 1240441E 1240442E 1240958E 1240959E 1240960E 1241211E 1241212E 1241213E 1241777E 1241957E 1241958E 1241959E 1241960E 1241961E 1241962E 1241963E 1241964E 1242046E 1242047E 1242048E 1242413E 1242414E 1242415E 1242416E 1242650E 1242651E 1242652E 1242653E 1242654E 1243519E 1243539E 1243592E 1243593E…

FDA’s list runs to 3,023 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 - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

These words name no state.

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?

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.

Source:

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

  • The firm began the recall on Nov 17, 2014.
  • FDA classified it on Dec 17, 2014.
  • FDA’s Enforcement Report published it on Dec 24, 2014.
  • FDA terminated it on Jul 17, 2015.
Source:

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

Who is recalling it?

  • Stryker Endoscopy, of San Jose, CA.
  • 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 3,023 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.

An example record, made up for this guide

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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Every fact names its source.

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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