activforce 2 package labeling: Model: Activ5-M R 201-200563 — FDA record Z-0386-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 30, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
activforce 2 package labeling: Model: Activ5-M R 201-200563
Reason
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.
Classification
Class II
Recalling firm
Activbody, Inc.
Quantity
145 kits in U.S.
Agency-reported status
Ongoing
Source record identifier
Z-0386-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityActivforce 2 Serial Numbers: 5M1011012046AK7655 5M1011012046AK7556 5M1011012046AK7557 5M1011012046AK7559 5M1011012046AK7560 5M1011012046AK7561 5M1011012046AK7562 5M1011012046AK7563 5M1011012046AK7564 5M1011012046AK7565 5M1011012046AK7566 5M1011012046AK7567 5M1011012046AK7568 5M1011012046AK7569 5M1011012046AK7570 5M1011012046AK7571 5M1011012046AK7572 5M1011012046AK7573 5M1011012046AK7574 5M1011012046AK7575 5M1011012046AK7576 5M1011012046AK7577 5M1011012046AK7578 5M1011012046AK7579 5M1011012046AK7580 5M1011012046AK7581 5M1011012046AK7582 5M1011012046AK7583 5M1011012046AK7584 5M1011012046AK7585 5M1011012046AK7586 5M1011012046AK7587 5M1011012046AK7588 5M1011012046AK7589 5M1011012046AK7590 5M1011012046AK7591 5M1011012046AK7592 5M1011012046AK7593 5M1011012046AK7594 5M1011012046AK7595 5M1011012046AK7596 5M1011012046AK7597 5M1011012046AK7598 5M1011012046AK7599 5M1011012046AK7600 5M1011012046AK7601 5M1011012046AK7602 5M1011012046AK7603 5M1011012046AK7604 5M1011012046AK7605 5M1011012046AK7606 5M1011012046AK7607 5M1011012046AK7608 5M1011012046AK7609 5M1011012046AK7610 5M1011012046AK7611 5M1011012046AK7612 5M1011012046AK7613 5M1011012046AK7614 5M1011012046AK7615 5M1011012046AK7616 5M1011012046AK7617 5M1011012046AK7618 5M1011012046AK7619 5M1011012046AK7620 5M1011012046AK7621 5M1011012046AK7622 5M1011012046AK7623 5M1011012046AK7624 5M1011012046AK7625 5M1011012046AK7626 5M1011012046AK7627 5M1011012046AK7628 5M1011012046AK7629 5M1011012046AK7630 5M1011012046AK7631 5M1011012046AK7632 5M1011012046AK7633 5M1011012046AK7634 5M1011012046AK7635 5M1011012046AK7636 5M1011012046AK7637 5M1011012046AK7638 5M1011012046AK7639 5M1011012046AK7640 5M1011012046AK7641 5M1011012046AK7642 5M1011012046AK7643 5M1011012046AK7644 5M1011012046AK7645 5M1011012046AK7646 5M1011012046AK7647 5M1011012046AK7648 5M1011012046AK7649 5M1011012046AK7650 5M1011012046AK7651 5M1011012046AK7652 5M1011012046AK7653 5M1011012046AK7654 5M1011012102AL7776 5M1011012102AL7777 5M1011012102AL7778 5M1011012102AL7779 5M1011012102AL7780 5M1011012102AL7781 5M1011012102AL7783 5M1011012102AL7784 5M1011012102AL7785 5M1011012102AL7786 5M1011012102AL7787 5M1011012102AL7788 5M1011012102AL7789 5M1011012102AL7790 5M1011012102AL7791 5M1011012102AL7792 5M1011012102AL7793 5M1011012102AL7794 5M1011012102AL7795 5M1011012102AL7796 5M1011012102AL7797 5M1011012102AL7798 5M1011012102AL7799 5M1011012102AL7800 5M1011012102AL7801 5M1011012102AL7802 5M1011012102AL7803 5M1011012102AL7804 5M1011012102AL7805 5M1011012102AL7806 5M1011012102AL7807 5M1011012102AL7808 5M1011012102AL7809 5M1011012102AL7810 5M1011012102AL7811 5M1011012102AL7812 5M1011012102AL7813 5M1011012102AL7814 5M1011012102AL7815 5M1011012102AL7816 5M1011012102AL7817 5M1011012102AL7818 5M1011012102AL7819 5M1011012102AL7820 5M1011012102AL7821 5M1011012102AL7822 5M1011012102AL7823 5M1011012102AL7824 5M1011012102AL7825 5M1011012102AL7826 5M1011012102AL7827 5M1011012102AL7828 5M1011012102AL7829 5M1011012102AL7830 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5M1011012102AL8257 5M1011012102AL8258 5M1011012102AL8259 5M1011012102AL8260 5M1011012102AL8261 5M1011012102AL8262 5M1011012102AL8263 5M1011012102AL8264 5M1011012102AL8265 5M1011012102AL8266 5M1011012102AL8267 5M1011012102AL8268 5M1011012102AL8269 5M1011012102AL8270 5M1011012102AL8271 5M1011012102AL8272 5M1011012102AL8273 5M1011012102AL8274 5M1011012102AL8275 5M1011012102AL8276 5M1011012102AL8277 5M1011012102AL8278 5M1011012102AL8279 5M1011012102AL8280 5M1011012102AL8281 5M1011012102AL8282 5M1011012102AL8283 5M1011012102AL8284 5M1011012102AL8285 5M1011012102AL8286 5M1011012102AL8287 5M1011012102AL8288 5M1011012102AL8289 5M1011012102AL8290 5M1011012102AL8291 5M1011012102AL8292 5M1011012102AL8293 5M1011012102AL8294 5M1011012102AL8295 5M1011012102AL8296 5M1011012102AL8297 5M1011012102AL8298 5M1011012102AL8299 5M1011012102AL8300 5M1011012102AL8301 5M1011012102AL8303 5M1011012102AL8304 5M1011012102AL8305 5M1011012102AL8306 5M1011012102AL8307 5M1011012102AL8308 5M1011012102AL8309 5M1011012102AL8310 5M1011012102AL8311 5M1011012102AL8312 5M1011012102AL8313 5M1011012102AL8314 5M1011012102AL8315 5M1011012102AL8316 5M1011012102AL8317 5M1011012102AL831...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Dec 22, 2021
Recall initiation date
Nov 30, 2021
Center classification date
Dec 16, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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