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Use caution Medical device recall · FDA · Published October 28, 2021

Osteomed OsteoPower Power Console: Electrical Safety Recall - Risk of Patient Shock

Osteomed recalls OsteoPower Power Console 2 and 2i models due to electrical safety compliance issues with IEC 60601 standards, which may have caused patient shocks. Affected units include specific model numbers and serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0335-2022Medical deviceOsteomed ›
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Contact the company

Recalling firmOsteomed, LLC3885 Arapaho Rd · Addison, TX 75001-4314
✎ GovInfoNow plain-language explainer

Osteomed is recalling several models of OsteoPower Power Consoles and footswitches because they don't meet the latest electrical safety standards (IEC 60601), which could have caused patient shocks. This is a safety issue that requires immediate attention. Read more at govinfonow.com/recall/61623-osteomed-osteopower-power-console-electrical-safety-recall-risk-of-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/61623-osteomed-osteopower-power-console-electrical-safety-recall-risk-of-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0335-2022

Cite this page

“Osteomed OsteoPower Power Console: Electrical Safety Recall - Risk of Patient Shock.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61623-osteomed-osteopower-power-console-electrical-safety-recall-risk-of-patient. Based on FDA recall #Z-0335-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0335-2022%22&limit=1).

Osteomed, LLC recalled OsteoMed OsteoPower Power Consoles and footswitches due to non-compliance with electrical safety standards that shocked a patient, the FDA said on Oct. 28, 2021.

How to tell if you have it

  • OsteoMed OsteoPower Power Console 2 REF 450-0021-00
  • OsteoMed D-Power Control Console 2 REF 450-0021-01
  • Power Control Console 2 REF ECOS-450-0021-00
  • OsteoMed OsteoPower Power Console 2i REF 450-0005-00
  • OsteoMed D-Power Control Console 2i REF 450-0005-01
  • Power Control Console 2i REF ECOS-450-0005-00
  • OsteoMed BMF Footswitch REF 450-0390
  • D-Bi-Directional Master Footswitch REF 450-0380
  • D-Uni-Directional Footswitch II REF 450-0350
  • D-Bi-Directional Footswitch II REF 450-0360
  • D-Uni-Directional Master Footswitch REF 450-0370

The hazard

The consoles are not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

Context

GovInfoNow's records show Osteomed, LLC has 2 other recalls on record since 2020-04-02. On 2023-05-31, Osteomed recalled 1.6mm x 4mm Profile Zero Auto-Drive Screws due to the risk of screw passing through plate hole. On 2020-04-02, Osteomed recalled OSTEOVATIONEX 3CC ImpactFormula kits because of incorrect shelf-life risk. Other recent recalls of similar products include Stryker Neptune Smart Docking Station Recall (2026-05-06), GE Allia Moveo X-ray System Recall (2026-04-20) and Boston Scientific StoneSmart Connect Console Power Adapters May Fail Safety Testing (2026-07-22).

How to tell if you have this one

Check if your device has the model numbers listed: OsteoPower Power Console 2 (REF 450-0021-00), OsteoPower Power Console 2i (REF 450-0005-00), D-Power Control Console 2 (REF 450-0021-01), or D-Power Control Console 2i (REF 450-0005-01). Also, verify the serial numbers provided in the recall notice.

  • Brand
    Osteomed
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number on your device: OsteoPower Power Console 2 (REF 450-0021-00), OsteoPower Power Console 2i (REF 450-0005-00), D-Power Control Console 2 (REF 450-0021-01), or D-Power Control Console 2i (REF 450-0005-01).

  2. Verify Serial Number

    Check if your device's serial number matches any listed in the recall notice (e.g., 0422006, 450-0005-00, etc.).

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 39 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI. The…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Oct 28, 202112. FDA classified it Class II: Dec 6, 202123. Published in FDA’s Enforcement Report: Dec 15, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-0335-2022 (October 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0335-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA