PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting,…
Medical device recall Z-0720-2015. Published in FDA’s Enforcement Report on Dec 24, 2014.
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.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 180,573 units total 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?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 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 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
41466 41467 41729 41883 41892 42212 42256 42312 42811 43249 44279 70809 71009 71309 72209 80409 804092 90809 1008091 1008092 1008093 1008094 1008095 100909 1112011 01112011A 01112011D 141531 141532 142480 142481 142482 143197 143208…
Every code shown here, 1,992 characters
41466 41467 41729 41883 41892 42212 42256 42312 42811 43249 44279 70809 71009 71309 72209 80409 804092 90809 1008091 1008092 1008093 1008094 1008095 100909 1112011 01112011A 01112011D 141531 141532 142480 142481 142482 143197 143208 0200178B 0200199C 0200200C 02022012E 2132014 02202013E 0244651B 0244851C 0244852C 0244853C 0245331C 0245528C 0245530C 0245531C 0245836C 0245837C 0245838C 0246753C 0246957C 0246958C 0246960C 0247433C 3012011 0341069C 0341543C 0341544C 0341916C 0341917C 0341919C 3419210 0344507C 0344509C 0344513C 0344515C 0344516C 0344519C 0344522C 0344523C 0344526C 0344527C 4012014 040313D 04122011E 04122011T 0443870C 0443871C 0443873C 0443874C 0443875C 0443876C 0443878C 0443879C 0443884D 0443886D 0443887D 0443888D 0443889D 0443890D 0443891D 0443893D 0445107C 5062010 51120102 05162013D 0542119D 0542336D 0542337D 0542338D 0542440D 0542447D 0542449D 0542450D 0542556D 0542558D 0542561D 0542563D 0542564D 0542565D 0543337D 06122013D 6152011 6242010 06272012D 06272013D 0641938D 0641939D 0641942D 0641943D 0641944D 0641947D 0641948D 0641949D 0641950D 0641952D 0641955D 0641956D 0641957D 0641962D 0646241D 0646244D 0646246D 0646249D 0646252D 0646255D 0646258D 0646259D 0646260D 0646262D 0646264D 0646265D 0646266D 0646267D 0646268D 0646270D 0646271D 0646272D 0646273D 0646274D 0646275D 0647210D 06CON05659 06CON05767 06CON05768 06CON06068 06CON06069 06CON06070 06CON06124 06CON08797 06CON08798 7082011 7092014 7102014 07122013D 71309 713092 713093 71409 714091 714092 07232013D 0746365D 0746690D 0746692D 0746693D 0746695D 0746696D 0746698D 0746699D 0746732D 0746734D 0746736D 0746738D 08012013D 08022013D 8082013 08152013D 08292013D 0842561D 842811 0843219D 0843221D 0843225D 0843226D 0843227D 0843235D 0843236D 0843239D 0843240D 0843241D 0843243D 0843245D 0843251D 0843255D 0843257D 0843259D 0843261D 0843263D 0843266D 0843268D 0843704D 0847900D 0847906D 0847908D 0847911D 0847912D 0847915D 0847917D 0847921D 0847925D 0847928D 0847931D 0847933D 0847937D 0847939D 0847943D…
FDA’s list runs to 5,256 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 - 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.
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.
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.
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.
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 5,256 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.