PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting,…
Medical device recall Z-0755-2015. 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 MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 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
42796 42801 42802 42804 43268 44023 44024 1192011 143481 0200156B 0244656B 0245398C 0246061C 0246312C 0246366C 0246986C 3222012 0341249C 0344478C 04132012E 0441343C 0441354C 0441355C 0444499C 0444505D 0445113C 0542481D 0542486D 0542488D…
Every code shown here, 1,992 characters
42796 42801 42802 42804 43268 44023 44024 1192011 143481 0200156B 0244656B 0245398C 0246061C 0246312C 0246366C 0246986C 3222012 0341249C 0344478C 04132012E 0441343C 0441354C 0441355C 0444499C 0444505D 0445113C 0542481D 0542486D 0542488D 0542514D 06272013E 0641983D 0641985D 0641990D 0641991D 0641993D 0641996D 0641998D 0641999D 0642003D 0647975D 06CON02508 06CON05664 06CON06127 06CON08812 07232013E 7282014 0742752D 0742755D 0744892D 0744893D 0744894D 0744895D 0744899D 0744902D 0744905D 0744907D 0744908D 0744910D 0744911D 08012013E 08022013E 0812011E 8122010 08152013E 08292013E 0841786D 0842288D 8422890 0842290D 0842292D 0842294D 0842298D 09192013E 0940016D 0940020D 0940023D 0940026D 0940029D 0940032D 0940038D 0940043D 0940049D 0940053D 0940059D 0940066D 0940072D 0940076D 0940081D 0940089D 0940094D 0940097D 0940103D 0940109D 0940115D 0944842D 0944843D 0944848D 0944850D 0944853D 0944857D 0944858D 0944861D 0944864D 0944867D 0944869D 0944872D 0944876D 0944880D 0944881D 0944884D 0944890D 0944895D 0944899D 0944901D 0944904D 0944907D 0944908D 0944913D 0944917D 0944923D 1042517D 1042519D 1044896D 1044897D 1044899D 1045191D 1045202D 1045204D 1045385D 1045387 1045387D 1045389D 1045936D 1045939D 1045941D 1045943D 1046169D 1046737D 1046738D 1046741D 1046742D 11172011E 1140697D 1140698D 1140699D 1141724D 1141725D 1141728D 1141730D 1142227D 1142228D 1142411D 1142412D 1143086D 1143087D 1143440D 1143441D 1144680D 1144681D 1144683D 1144685D 1144686D 1144688D 1144690D 1144897D 1144898D 1144899D 1145468D 1145469D 1145470D 1145472D 1146373D 1146374D 1146375D 1146389D 1146391D 1146393 1146393D 1146395D 1146396D 1146398D 1146711D 1146712D 1146713D 1146716D 1146718D 1146843D 1240626D 1240627D 1240963D 1240964 1240964D 1240965 1240966 1240967 1240967D 1240968 1240969 1240970 1242396 1243805 1243805D 1243806 1244703 1244703D 1244704 1245037 1245038 1245039 1245040 1245041 1245095 1245097 1245098 1245100 1245103 1245860 1245860D 1245861 1245862 1246032 1341115 1341115H 1341243 1341244…
FDA’s list runs to 2,735 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 2,735 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.