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Use caution Medical device recall · FDA · Published May 8, 2018

Stryker Reprocessed HARMONIC Ace+7 Shears May Show Error Code - Stop Using

Stryker recalls reprocessed HARMONIC Ace+7 shears that may show 'No Instrument Uses Remaining' error code, preventing use. Affected units may need replacement.

🇺🇸 FDA recall #Z-2484-2018Medical deviceStryker ›
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Contact the company

Recalling firmStryker Sustainability Solutions1810 W Drake Dr · Tempe, AZ 85283-4327
✎ GovInfoNow plain-language explainer

Stryker is recalling reprocessed HARMONIC Ace+7 shears that may display an error code when first connected to the generator, making them unusable. This affects medical devices used for precise cutting and hemostasis in surgeries. Read more at govinfonow.com/recall/71172-stryker-reprocessed-harmonic-ace-7-shears-may-show-error-code.

Source Summary by GovInfoNow · govinfonow.com/recall/71172-stryker-reprocessed-harmonic-ace-7-shears-may-show-error-code · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2484-2018

Cite this page

“Stryker Reprocessed HARMONIC Ace+7 Shears May Show Error Code - Stop Using.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71172-stryker-reprocessed-harmonic-ace-7-shears-may-show-error-code. Based on FDA recall #Z-2484-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2484-2018%22&limit=1).

The FDA announced on May 8, 2018, that Stryker Sustainability Solutions is recalling Reprocessed HARMONIC Ace¿ +7 shears because they may display an error code preventing use. The agency issued recall number Z-2484-2018 for the Class II device.

How to tell if you have it

  • Brand: Stryker
  • Product: Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH)
  • Item Number: HARH36
  • Lot number: 7656512
  • Quantity: 180 units

The hazard

Stryker Sustainability Solutions reported an increase in cases where the affected devices display a "No Instrument Uses Remaining" error code upon initial connection to the generator. This error prevents the device from being used.

Context

GovInfoNow's records show Stryker Sustainability Solutions has had 22 other recalls on record since December 1, 2017. Other recent recalls of similar products include Stryker XCEL Bladeless Trocar W/Optiview (August 19, 2026), Bard EP XT Decapolar Catheter (August 18, 2026), and Stryker Daig Livewire Steerable BDB Catheter (April 10, 2026).

How to tell if you have this one

Check for the product name 'HARMONIC Ace+7, 5mm Diameter Shears with Advanced Hemostasis (HARH)' and item number HARH36. The affected units were sold with lot number 7656512.

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

What to do — step by step

  1. Check for Error Code

    Look for the error code 'No Instrument Uses Remaining' when connecting the shears to the generator.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Louisiana, Maryland, Massachusetts, Montana, New York, North Carolina, Pennsylvania, Tennessee, Texas.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: May 8, 201812. FDA classified it Class II: Jul 18, 201823. Published in FDA’s Enforcement Report: Jul 25, 201834. FDA terminated the recall: Jul 29, 2019420182019
  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

Are there any safety risks?

The shears may not function properly, potentially leading to incomplete procedures or complications during surgery.

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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-2484-2018 (May 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2484-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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