Box Label: activ5 TINY GYM IN YOUR POCKET activbody
Medical device recall Z-0385-2022. Published in FDA’s Enforcement Report on Dec 22, 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 Dec 22, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 44 states named in where it went
- 501 kits 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?
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.
501 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Activforce Kit Number: AB0000-AC5540 Serial Numbers: 5P1011011708AB0000 5P1011011708AB0001 5P1011011708AB0002 5P1011011708AB0003 5P1011011708AB0004 5P1011011708AB0005 5P1011011708AB0006 5P1011011708AB0007 5P1011011708AB0008…
Every code shown here, 1,991 characters
Activforce Kit Number: AB0000-AC5540 Serial Numbers: 5P1011011708AB0000 5P1011011708AB0001 5P1011011708AB0002 5P1011011708AB0003 5P1011011708AB0004 5P1011011708AB0005 5P1011011708AB0006 5P1011011708AB0007 5P1011011708AB0008 5P1011011708AB0009 5P1011011708AB0010 5P1011011708AB0011 5P1011011708AB0012 5P1011011708AB0013 5P1011011708AB0014 5P1011011708AB0015 5P1011011708AB0016 5P1011011708AB0017 5P1011011708AB0018 5P1011011708AB0019 5P1011011708AB0020 5P1011011708AB0021 5P1011011708AB0022 5P1011011708AB0023 5P1011011708AB0024 5P1011011708AB0025 5P1011011708AB0026 5P1011011708AB0027 5P1011011708AB0028 5P1011011708AB0029 5P1011011708AB0030 5P1011011708AB0031 5P1011011708AB0032 5P1011011708AB0033 5P1011011708AB0034 5P1011011708AB0035 5P1011011708AB0036 5P1011011708AB0037 5P1011011708AB0038 5P1011011708AB0039 5P1011011708AB0040 5P1011011708AB0041 5P1011011708AB0042 5P1011011708AB0043 5P1011011708AB0044 5P1011011708AB0045 5P1011011708AB0046 5P1011011708AB0047 5P1011011708AB0048 5P1011011708AB0049 5P1011011708AB0050 5P1011011708AB0051 5P1011011708AB0052 5P1011011708AB0053 5P1011011708AB0054 5P1011011708AB0055 5P1011011708AB0056 5P1011011708AB0057 5P1011011708AB0058 5P1011011708AB0059 5P1011011708AB0060 5P1011011708AB0061 5P1011011708AB0062 5P1011011708AB0063 5P1011011708AB0064 5P1011011708AB0065 5P1011011708AB0066 5P1011011708AB0067 5P1011011708AB0068 5P1011011708AB0069 5P1011011708AB0070 5P1011011708AB0071 5P1011011708AB0072 5P1011011708AB0073 5P1011011708AB0074 5P1011011708AB0075 5P1011011708AB0076 5P1011011708AB0077 5P1011011708AB0078 5P1011011708AB0079 5P1011011708AB0080 5P1011011708AB0081 5P1011011708AB0082 5P1011011708AB0083 5P1011011708AB0084 5P1011011708AB0085 5P1011011708AB0086 5P1011011708AB0087 5P1011011708AB0088 5P1011011708AB0089 5P1011011708AB0090 5P1011011708AB0091 5P1011011708AB0092 5P1011011708AB0093 5P1011011708AB0094 5P1011011708AB0095 5P1011011708AB0096 5P1011011708AB0097 5P1011011708AB0098 5P1011011708AB0099 5P1011011708AB0100 5P1011011708AB0101…
FDA’s list runs to 295,339 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.
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. O.U.S.: Not provided
The states and territories these words name
44 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Nov 30, 2021.
- FDA classified it on Dec 16, 2021.
- FDA’s Enforcement Report published it on Dec 22, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Activbody, Inc., of San Diego, 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 295,339 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.