Z-1098-2020Class II

Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75...

Name: Z-1098-2020 Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2020-01-13
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2020-01-13 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Telescopic 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... on 2020-01-13. FDA classified it as Class II and gives the reason as "Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1098-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-13
Posted: 2020-01-28
Terminated: 2021-08-10
Recalling firm: Stryker Corp.
Product: Telescopic 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
FDA root cause: Under Investigation by firm
Action: On January 13, 2020, the firm informed customers of the recall via Urgent Medical Device Recall Notification letters. Customers were advised to take the following actions: 1. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any recalled Stryker SafeAir Smoke Evacuation Pencils or LINA Telescopic Smoke Pencils. 2. Complete the Business Reply Form (BRF) to confirm receipt of Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Return the completed BRF via fax to 8665212762 or email to [email protected]. 3. If you have further distributed this product, please forward the notification to all affected locations. 4. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which should be used to return recalled product. Upon receipt of the recalled product, a credit will be applied to your account.
Quantity in commerce: 15150
Distribution: Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Product codes and lots: 1923011, 1923050, 1924004, 1924005, 1924015, 1929038, 1929039, 1929055

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1098-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1097-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-06
Z-1098-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-06
Z-1099-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-06

Product code GEI

K182354Class IISafeAir Telescopic Smoke PencilLina Medical Aps / cleared 2018-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)