PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233
Medical device recall Z-0623-2015. 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, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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. 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
42358 42361 44292 44306 102110 1092012 123010 140323 140337 0200294C 2092012 2172014 0245175C 0245377C 0245381C 0245820C 0245821C 0245832C 0245891C 0246317C 0246318C 0246930C 0247039C 0247041C 3122014 0341227C 0341901C 0344750C 04192012E…
Every code shown here, 1,999 characters
42358 42361 44292 44306 102110 1092012 123010 140323 140337 0200294C 2092012 2172014 0245175C 0245377C 0245381C 0245820C 0245821C 0245832C 0245891C 0246317C 0246318C 0246930C 0247039C 0247041C 3122014 0341227C 0341901C 0344750C 04192012E 04232013E 42499 04262013D 0442448C 0442451C 0442454C 0442457C 0442458C 0442460C 0442463C 0442465C 0442466C 0442467C 0442470D 05102011E 5132010 5262010 0541369D 0541374D 0541377D 0541381D 0541388D 0541390D 0541392D 0541393D 6022014 6142014 06182012E 6202014 6222014 6232014 0640125D 0640129D 0640131D 0640132D 0640133D 0640135D 0640137D 0640138D 0640140D 0640141D 0640146D 0640906D 0643123D 0643124D 0643125D 0643126D 0643127D 0643128D 0643130D 0643131D 0643134D 0643135D 0643136D 0643137D 0643138D 0643139D 0643140D 0646331D 0646997D 646998 0646998D 0646999D 0647000D 0647001D 0647002D 0647004D 0647006D 0647008D 0647009D 0647010D 0647012D 0647014D 0647015D 0647016D 0647018D 0647019D 0647020D 0647021D 0647023D 0647024D 0647025D 0647026D 0647027D 0647028D 0647029D 0647031D 0647032D 0647034D 0647035D 0647036D 0647037D 06CON02507 7012010 07022013D 07032013D 7072014 0747491D 8152014 8182010 8272014 0840681D 0845166D 0845167D 0845171D 0845173D 0845176D 0845179D 0845184D 0845185D 0845186D 0845189D 0845190D 0845192D 0845197D 0845198D 0845205D 0845207D 0845208D 0845212D 0845213D 0845215D 0845217D 0845222D 0845223D 0845225D 0845231D 0845233D 0845234D 0845238D 9052014 9282010 09292010A 0940590D 0943416D 0943549D 0943561D 0943562D 0943565D 0943568D 0943569D 0943571D 0943574D 0943576D 0943577D 0943580D 0943581D 0943588D 0943590D 0943591D 0943597D 0943599D 0943602D 0943606D 0943608D 0943611D 0944130D 0944143D 0944147D 0944204D 0944205D 0944206D 0944814D 0945234D 0945885D 945996 1022031E 10302013 1040253D 1040283D 1042096D 1042235D 1042236D 1042505D 1042507D 1042508D 1043577D 1046167D 1046840D 1046842D 1046844D 1046845D 1046847D 11132013 1140932D 1141738D 1141740D 1142235D 1142236D 1142237D 1142637D 1142638D 1142639D 1143098D 1143099D 1143448D 1143450D…
FDA’s list runs to 2,862 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 2,862 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.