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Lower risk Medical device recall · FDA · Published January 19, 2021

ReNovo Recalls Sterile Surgical Shavers Due to Non-Sterile Products

ReNovo recalls reprocessed surgical shavers and devices labeled sterile but containing non-sterile products. This could lead to infection risks during medical procedures.

🇺🇸 FDA recall #Z-1159-2021Medical deviceReNovo ›
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Recalling firmReNovo, Inc.340 Sw Columbia St · Bend, OR 97702-1035
✎ GovInfoNow plain-language explainer

What happened, in plain English

ReNovo has recalled several reprocessed surgical devices that were shipped as sterile but actually contain non-sterile components. Using these products could increase infection risk during medical procedures. Read more at govinfonow.com/recall/63366-renovo-recalls-sterile-surgical-shavers-due-to-non-sterile-products.

Source Summary by GovInfoNow · govinfonow.com/recall/63366-renovo-recalls-sterile-surgical-shavers-due-to-non-sterile-products · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1159-2021

Cite this page

“ReNovo Recalls Sterile Surgical Shavers Due to Non-Sterile Products.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63366-renovo-recalls-sterile-surgical-shavers-due-to-non-sterile-products. Based on FDA recall #Z-1159-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1159-2021%22&limit=1).

Why it’s dangerous

The recalled products were labeled as sterile but were shipped with non-sterile components. This means they could introduce infections during medical procedures if used improperly.

Who’s affected

Medical professionals and hospitals that use ReNovo's reprocessed surgical shavers and devices. Patients undergoing procedures with these devices face potential infection risks.

How to tell if you have this one

Check for lot numbers L-008926-16037, L-008918-16048, L-008918-16045, L-008936-16275, or L-008933-16078 on the packaging or labels of reprocessed surgical shavers and devices.

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

What to do — step by step

  1. Check Product Lot Numbers

    Look for lot numbers L-008926-16037, L-008918-16048, L-008918-16045, L-008936-16275, or L-008933-16078 on the packaging or labels of reprocessed surgical shavers and devices.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of CA, NJ and OR.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, New Jersey, Oregon.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Jan 19, 202112. FDA classified it Class II: Mar 2, 202123. Published in FDA’s Enforcement Report: Mar 10, 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-1159-2021 (January 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1159-2021 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