Lower riskMedical device recall · FDA · Published November 30, 2021
Activbody Activ5 TINY GYM IN YOUR POCKET: Inaccurate force measurement may lead
Activbody recalls 1700+ Activ5 TINY GYM devices due to manufacturing issues causing inaccurate force measurements that could lead to incorrect treatment planning. The company also failed to register medical devices with the FDA.
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.
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Contact the company
📍Recalling firmActivbody, Inc.4435 Eastgate Mall · San Diego, CA 92121-1982
“Activbody Activ5 TINY GYM IN YOUR POCKET: Inaccurate force measurement may lead.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61487-activbody-activ5-tiny-gym-in-your-pocket-inaccurate-force-measurement. Based on FDA recall #Z-0385-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0385-2022%22&limit=1).
The FDA has issued a Class II recall for an insulin pump device due to potential delivery inaccuracies.
How to tell if you have it
Product: Insulin Pump
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
The hazard
The device poses a risk of inaccurate insulin delivery.
Context
This recall follows other recent safety actions in the medical device sector, including a MiniMed Flex Insulin Pump recall in August 2026 and a Micro Therapeutics Pipeline Flex Embolization Device recall in June 2026.
How to tell if you have this one
Check your Activ5 device for the model number starting with 'Activ5' and serial numbers listed in the recall (5P1011011708AB0000 to 5P1011011708AB1703).
Brand
Activbody
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
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
Look for the model number starting with 'Activ5' and serial numbers between 5P1011011708AB0000 and 5P1011011708AB1703.
Where it went and when
Where it was distributed
Distributed in 42 states and D.C. and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0385-2022 (November 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0385-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.