PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234
Medical device recall Z-0624-2015. 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, W/RATCHET, INSULATED SHAFT, P/N 0250080234. 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
42178 42259 42260 42263 42267 42325 42326 42791 70109 713091 72309 90809 1192010 140575 140800 140807 140864 141289 141292 141401 0200154B 0200176B 0200177B 0245386C 0246314C 0246934C 0246939C 0246940C 0246942C 0247044C 0247047C 0247049C…
Every code shown here, 1,993 characters
42178 42259 42260 42263 42267 42325 42326 42791 70109 713091 72309 90809 1192010 140575 140800 140807 140864 141289 141292 141401 0200154B 0200176B 0200177B 0245386C 0246314C 0246934C 0246939C 0246940C 0246942C 0247044C 0247047C 0247049C 0340029C 0340679C 0340680C 0340681C 0340682C 0340683C 0341237C 0341241C 0341908C 0341912C 4122011 04242012E 04282011E 0441389C 0441455C 0441456C 441457 0441461C 0441464C 0441465C 0441466C 0441467C 0441468C 0441471C 0441472C 0443282C 0443519C 5022011 5112010 5212010 52120101 52120102 52120103 52120104 05232013D 5252010 0540672D 0540867D 0540868D 0540869D 0540871D 0540872D 0540873D 0540874D 0540877D 0540878D 0540880D 0540881D 0540884D 06040590D 06122012E 6162014 6172011 6272012 06272012E 0640590D 0640591D 0640595D 0640596D 0640606D 0640607D 0640608D 640609 0640610D 0640611D 0640612D 0640613D 0640614D 0640615D 0647215D 06CON06064 06CON06123 06CON06666 7022012 7232014 0741767D 0741768D 0741770D 0741772D 0741773D 0741774D 0741776D 0741777D 0741778D 0745271D 0745276D 0745277D 0745278D 0745279D 0745280D 0745281D 0745282D 0840677D 0840768D 0841627D 0841630D 0841636D 0841640D 0841644D 0841648D 0841648E 0841652D 0841690D 0841699D 0841709D 0841720D 0842601D 0846857D 0846858D 0846860D 0846863D 0846866D 0846873D 0846878D 0846883D 0846887D 0846893D 0846900D 0846904D 0846910D 0846919D 0846923D 0846928D 0846935D 0846944D 0846948D 90209 9072010 9232013 9252012 0944346D 0944349D 0944350D 0944355D 0944360D 0944361D 0944365D 0944368D 0944369D 0944370D 0944375D 0944377D 0944380D 0944382D 0944387D 0944391D 0944393D 0944398D 0944402D 0944404D 0944409D 0944790D 0944795D 0944796D 0946948D 1042510D 1044586D 1045207D 1045209D 10456684D 1045680D 1045681D 1045684D 1046169D 1046170D 1046859D 1046861D 1046863D 1046864D 1046868D 1046869D 1046875D 111299 1141741D 1141742D 1142182D 1142183D 1142184D 1143443D 1143444D 1143445D 1145111D 1145112D 1145474D 1145475D 1145637D 1146568D 1146569D 1146570D 1146571D 1240176D 1240177D 1240566D 1240567D 1240956D 1241215D…
FDA’s list runs to 2,586 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 2,586 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.