Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy…
Medical device recall Z-2240-2021. Published in FDA’s Enforcement Report on Aug 18, 2021.
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 18, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 13 states named
- 96 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?
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
96 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 540042X001 540042X002 540042X003 540042X004 540042X005 540042X006 540042X007 540042X008 540042X009 540042X010 540042X011 540042X012 540042X013 540042X014 540042X015 540042X016 540042X017 540042X018 540042X019 540042X020…
Every code shown here, 1,119 characters
Serial Numbers: 540042X001 540042X002 540042X003 540042X004 540042X005 540042X006 540042X007 540042X008 540042X009 540042X010 540042X011 540042X012 540042X013 540042X014 540042X015 540042X016 540042X017 540042X018 540042X019 540042X020 540042X021 540042X022 540042X023 540042X024 540042X025 540042X026 540042X027 540042X028 540042X029 540042X030 540042X031 540042X032 540042X033 540042X034 540042X035 540042X036 540042X037 540042X038 540042X039 540042X040 540042X041 540042X042 540042X043 540042X044 540042X045 540042X046 540042X047 540042X048 540042X049 540042X050 540042X051 540042X052 540042X053 540042X054 540042X055 540042X056 540042X057 540042X058 540042X059 540042X060 540042X061 540042X062 540042X063 540042X064 540042X065 540042X066 540042X067 540042X068 540042X069 540042X070 540042X071 540042X072 540042X073 540042X074 540042X075 540042X076 540042X077 540042X078 540042X079 540042X080 540042X081 540042X082 540042X083 540042X084 540042X085 540042X086 540042X087 540042X088 540042X089 540042X090 540042X091 540042X092 540042X093 540042X094 540042X095 540042X097 UDI-Device Identifier (GTIN/UPN):10884521592865
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.
US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
The states and territories these words name
13 states and territories.
Every one of them
- Alabama
- Arizona
- Connecticut
- Georgia
- Indiana
- Massachusetts
- Maryland
- Minnesota
- New York
- Ohio
- Texas
- Virginia
- Washington
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 23, 2021.
- FDA classified it on Aug 10, 2021.
- FDA’s Enforcement Report published it on Aug 18, 2021.
- FDA terminated it on Jan 28, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien Llc, of Mansfield, MA.
- 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.”
- 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.