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Use caution Medical device recall · FDA · Published January 13, 2020

Stryker SafeAir Telescopic Smoke Evacuation Pencil Recall: Risk of Electrical Burns

Stryker recalls a 75-inch telescopic smoke evacuation pencil due to potential hairline fractures causing electrical arcing and burns to users or patients. Affected units have specific product numbers.

🇺🇸 FDA recall #Z-1097-2020Medical deviceStryker ›
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Contact the company

Recalling firmStryker Instruments Div. of Stryker Corporation4100 E Milham Ave · Portage, MI 49002-9704
✎ GovInfoNow plain-language explainer

Stryker is recalling a 75-inch telescopic smoke evacuation pencil because hairline fractures in a component could cause electrical arcing, leading to burns for the user or patient. This is a safety issue that requires immediate attention to prevent injury. Read more at govinfonow.com/recall/66058-stryker-safeair-telescopic-smoke-evacuation-pencil-recall-risk-of-electrical.

Source Summary by GovInfoNow · govinfonow.com/recall/66058-stryker-safeair-telescopic-smoke-evacuation-pencil-recall-risk-of-electrical · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1097-2020

Cite this page

“Stryker SafeAir Telescopic Smoke Evacuation Pencil Recall: Risk of Electrical Burns.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66058-stryker-safeair-telescopic-smoke-evacuation-pencil-recall-risk-of-electrical. Based on FDA recall #Z-1097-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1097-2020%22&limit=1).

The FDA announced on Jan. 13, 2020, that Stryker Instruments Div. of Stryker Corporation is recalling SafeAir Telescopic Smoke Evacuation Pencils due to potential hairline fractures. These defects could allow electrical current to arc, causing burns to patients or users. The agency classified the recall as Class II.

How to tell if you have it

  • SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004
  • UPC 37613327466332

The hazard

According to the FDA, hairline fractures in a component could allow electrical current to arc out of the device. This malfunction may result in a burn to the patient and/or user.

Context

GovInfoNow's records show Stryker Instruments Div. of Stryker Corporation has 11 other recalls on record since Oct. 16, 2017. Other recent recalls include Stryker SurgiCount+ Software Version 2.0.17 (June 15, 2022), Stryker Zyphr Disposable Cranial Perforator (Oct. 16, 2020), and Stryker Neptune E-SEP 165mm Blade Electrode (March 26, 2020). Other recent recalls of similar products include FUJIFILM FDR Visionary Suite CH-200 X-ray Device (Jan. 9, 2026), Stryker NICO BrainPath Shephard's Hook (Oct. 31, 2025), and Wilson-Cook Teslatome Sphincterotomes (Dec. 18, 2025).

How to tell if you have this one

This product is a 75-inch telescopic smoke evacuation pencil from Stryker. Product number 0703 046 004 is listed on the device. It was sold with UDI GTIN 37613327466332 and 1921032.

  • Brand
    Stryker
  • Product
    SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Recall numberProduct, codes & lots
Z-1097-2020SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332; 1921032
Z-1098-2020Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332; 1923011, 1923050, 1924004, 1924005, 1924015, 1929038, 1929039, 1929055
Z-1099-2020Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332; 1922042, 1924003, 1929040, 1929048
Based on the official FDA remedy

What to do — step by step

  1. Check Product Number

    Look for product number 0703 046 004 on the device.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Jan 13, 202012. FDA classified it Class II: Feb 6, 202023. Published in FDA’s Enforcement Report: Feb 12, 202034. FDA terminated the recall: Aug 10, 2021420202021
  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

Is this pencil dangerous if used properly?

The recall states that hairline fractures could cause electrical arcing, but the pencil is safe if no fractures exist. However, the hazard is present in some units.

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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-1097-2020 (January 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1097-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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