Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with…
Medical device recall Z-1861-2021. Published in FDA’s Enforcement Report on Jun 23, 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 Jun 23, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 278 units US; 7 units OUS 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?
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
278 units US; 7 units OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1504-314-00-1-0002 up to 2006-314-00-1-0185 ***UPDATED 12/10/21*** Recall expanded to include Rev 3. Complete list of recalled Serial Numbers: 1504-314-00-1-0002 1504-314-00-1-0003 1504-314-00-1-0004 1508-314-00-1-0005…
Every code shown here, 1,983 characters
Serial Numbers: 1504-314-00-1-0002 up to 2006-314-00-1-0185 ***UPDATED 12/10/21*** Recall expanded to include Rev 3. Complete list of recalled Serial Numbers: 1504-314-00-1-0002 1504-314-00-1-0003 1504-314-00-1-0004 1508-314-00-1-0005 1508-314-00-1-0006 1508-314-00-1-0007 1508-314-00-1-0008 1509-314-00-1-0009 1509-314-00-1-0010 1509-314-00-1-0011 1509-314-00-1-0012 1510-314-00-1-0013 1510-314-00-1-0014 1601-314-00-1-0016 1601-314-00-1-0017 1610-314-00-1-0018 1610-314-00-1-0019 1610-314-00-1-0020 1610-314-00-1-0021 1610-314-00-1-0022 1610-314-00-1-0023 1610-314-00-1-0024 1610-314-00-1-0025 1610-314-00-1-0026 1610-314-00-1-0027 1610-314-00-1-0028 1610-314-00-1-0029 1610-314-00-1-0030 1610-314-00-1-0031 1610-314-00-1-0032 1802-314-00-1-0033 1802-314-00-1-0034 1802-314-00-1-0035 1802-314-00-1-0036 1802-314-00-1-0037 1802-314-00-1-0038 1802-314-00-1-0039 1802-314-00-1-0040 1802-314-00-1-0041 1802-314-00-1-0042 1803-314-00-1-0043 1803-314-00-1-0044 1803-314-00-1-0045 1803-314-00-1-0046 1803-314-00-1-0047 1803-314-00-1-0048 1803-314-00-1-0049 1803-314-00-1-0050 1803-314-00-1-0051 1803-314-00-1-0052 1809-314-00-1-0053 1809-314-00-1-0054 1809-314-00-1-0055 1809-314-00-1-0056 1809-314-00-1-0057 1809-314-00-1-0058 1809-314-00-1-0059 1809-314-00-1-0060 1809-314-00-1-0061 1809-314-00-1-0062 1809-314-00-1-0063 1809-314-00-1-0064 1810-314-00-1-0065 1810-314-00-1-0066 1810-314-00-1-0067 1810-314-00-1-0068 1810-314-00-1-0069 1810-314-00-1-0070 1811-314-00-1-0071 1811-314-00-1-0072 1811-314-00-1-0073 1811-314-00-1-0074 1811-314-00-1-0075 1811-314-00-1-0076 1811-314-00-1-0077 1811-314-00-1-0078 1811-314-00-1-0079 1811-314-00-1-0080 1811-314-00-1-0083 1811-314-00-1-0084 1811-314-00-1-0085 1811-314-00-1-0087 1811-314-00-1-0088 1811-314-00-1-0089 1811-314-00-1-0090 1901-314-00-1-0091 1901-314-00-1-0092 1901-314-00-1-0093 1901-314-00-1-0094 1901-314-00-1-0095 1901-314-00-1-0096 1901-314-00-1-0097 1901-314-00-1-0098 1901-314-00-1-0099 1901-314-00-1-0100 1901-314-00-1-0101…
FDA’s list runs to 5,573 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 - US Nationwide and the countries of Australia, Japan.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 May 11, 2021.
- FDA classified it on Jun 15, 2021.
- FDA’s Enforcement Report published it on Jun 23, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Skytron, Div. The KMW Group, Inc, of Grand Rapids, 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 5,573 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.