Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Medical device recall Z-2156-2014. Published in FDA’s Enforcement Report on Aug 13, 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 Aug 13, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 2,460 units 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 firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
2,460 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part #’s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #’s: 01H0001 04G0251 06C0499 07G0748 08L1000 1018200054 1106200054 1202400194 1231200284 1320000054 01H0002 04G0252 06C0500 07G0749 08L1001 1018200064 1106200074…
Every code shown here, 1,998 characters
Part #’s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #’s: 01H0001 04G0251 06C0499 07G0748 08L1000 1018200054 1106200054 1202400194 1231200284 1320000054 01H0002 04G0252 06C0500 07G0749 08L1001 1018200064 1106200074 1202400204 1231200294 1320000064 01H0003 04G0253 06C0501 07G0750 08L1002 1018200074 1106200084 1202400214 1231200304 1320000074 01H0004 04G0254 06C0502 07G0751 08L1003 1018200084 1106700014 1202400224 1231200314 1320000084 01H0005 04G0255 06C0503 07G0752 08L1004 1018200094 1106700024 1202400234 1231200324 1320000094 01H0006 04G0256 06C0504 07G0753 08L1005 1018200104 1106800014 1202400244 1232000014 1320000104 01H0007 04G0257 06C0505 07G0754 08L1006 1018900014 1106800024 1203200214 1232000024 1320600014 01H0008 04G0258 06C0506 07G0755 09A1007 1018900024 1106800034 1203200224 1232000034 1320600024 01H0009 04G0263 06C0507 07G0756 09A1008 1018900034 1106800044 1203200234 1232000044 1320600034 01H0010 04G0264 06C0508 07G0757 09A1009 1018900044 1106800054 1203200244 1232000064 1320600044 01I0011 04H0259 06D0509 07G0758 09A1010 1018900054 1106800064 1203200254 1232000074 1320600054 01I0012 04H0260 06D0510 07G0759 09A1011 1018900064 1106800074 1203200274 1232000084 1320600064 01I0013 04H0261 06D0511 07G0760 09A1012 1018900074 1106800084 1203700954 1232600034 1321200214 01I0014 04H0265 06D0512 07G0761 09A1013 1018900084 1106800094 1203700964 1233400044 1321200224 01I0015 04H0266 06D0513 07H0762 09A1014 1018900094 1106800104 1203700974 1233400054 1321200234 01J0016 04H0267 06D0514 07H0763 09A1015 1018900104 1108100014 1203900024 1233400064 1321200244 01J0017 04H0268 06D0515 07H0764 09A1016 1019700014 1108100024 1204000044 1233900114 1321200254 01J0018 04H0269 06D0516 07H0765 09A1017 1019700024 1108100034 1204000054 1233900124 1321200264 01J0019 04H0270 06D0517 07H0766 09A1018 1019700034 1108100044 1204800264 1234000014 1321200274 01J0020 04I0262 06D0518 07H0767 09A1020 1019700044 1108100054 1205100514 1234000024 1321200284 01J0021 04I0271 06D0519…
FDA’s list runs to 23,677 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.
Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI & WV.
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
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.
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 Jun 24, 2014.
- FDA classified it on Aug 7, 2014.
- FDA’s Enforcement Report published it on Aug 13, 2014.
- FDA terminated it on Oct 27, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Instruments Div. of Stryker Corporation, of Portage, MI.
- 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 23,677 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.