Stryker Corporation: Device Recall

Recall Details

Recall Number

Z-0368-2025

Classification

Class II

Product Type

Device

Recalling Firm

Stryker Corporation

Status

Ongoing

Date Initiated

10/04/2024

Location

Portage, MI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,996,010 eaches

Reason for Recall

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

Product Description

Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-046-000

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.

Other Recalls by Stryker Corporation

• Class II: Risk 10/31/2025
  Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
• Class II: Risk 10/31/2025
  Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
• Class II: Risk 10/31/2025
  Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
• Class II: Risk 07/02/2025
  Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
• Class II: Risk 06/18/2025
  Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

View all recalls by Stryker Corporation →