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Use caution Medical device recall · FDA · Published October 14, 2019

Mizuho OSI Levo Arm Label Recall: Fluid Ingress Risk in Spinal Surgery Devices

Mizuho OSI recalls Levo Arm Label models 7887-050 and 7887-050R due to potential fluid ingress causing electrical failure and locking mechanism issues during spinal surgery. Affected units have serial numbers listed in the recall notice.

🇺🇸 FDA recall #Z-0091-2021Medical deviceMizuho OSI ›
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Recalling firmMizuho OSI30031 Ahern Ave · Union City, CA 94587-1234
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mizuho OSI is recalling Levo Arm Labels used in spinal surgery tables because fluid could enter the device and cause electrical problems, potentially failing the locking mechanism. This could lead to patient positioning issues during surgery if not fixed. Read more at govinfonow.com/recall/66792-mizuho-osi-levo-arm-label-recall-fluid-ingress-risk-in.

Source Summary by GovInfoNow · govinfonow.com/recall/66792-mizuho-osi-levo-arm-label-recall-fluid-ingress-risk-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0091-2021

Cite this page

“Mizuho OSI Levo Arm Label Recall: Fluid Ingress Risk in Spinal Surgery Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66792-mizuho-osi-levo-arm-label-recall-fluid-ingress-risk-in. Based on FDA recall #Z-0091-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2021%22&limit=1).

Why it’s dangerous

Fluid can enter the Levo Arm Label's electrical system, causing it to malfunction. This may lead to the locking mechanism failing during spinal surgery, potentially affecting patient positioning and safety.

Who’s affected

Spinal surgery patients and medical staff using Mizuho OSI Levo Arm Labels with serial numbers 201-452 (model 7887-050) or 234, 235, 248, 255, 341, 448 (model 7887-050R). Medical facilities using these specific units are most at risk.

How to tell if you have this one

Check if your Levo Arm Label has serial numbers 201-452 for model 7887-050 or 234, 235, 248, 255, 341, 448 for model 7887-050R. These units were sold with Mizuho OSI spinal surgery tables.

  • Brand
    Mizuho OSI
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Identify if your Levo Arm Label has serial numbers 201-452 (model 7887-050) or 234, 235, 248, 255, 341, 448 (model 7887-050R).

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 38 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: 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: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: 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 including in states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. 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, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 4 years after the firm started it.

1. Firm started the recall: Oct 14, 201912. FDA classified it Class II: Oct 9, 202023. Published in FDA’s Enforcement Report: Oct 21, 202034. FDA terminated the recall: Sep 27, 2023420192023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Do I need to stop using these Levo Arm Labels immediately?

The recall does not require immediate stop use; however, affected units should be checked and addressed as per the recall instructions.

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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-0091-2021 (October 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0091-2021 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