Stryker Corporation: Device Recall

Recall Details

Recall Number

Z-1138-2025

Classification

Class II

Product Type

Device

Recalling Firm

Stryker Corporation

Status

Ongoing

Date Initiated

01/08/2025

Location

Portage, MI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

622 units

Reason for Recall

Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

Product Description

stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

Distribution Pattern

Worldwide distribution.

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 →