Stryker Corporation: Device Recall

Recall Details

Recall Number

Z-1477-2025

Classification

Class II

Product Type

Device

Recalling Firm

Stryker Corporation

Status

Ongoing

Date Initiated

02/25/2025

Location

Portage, MI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

182,344 total units

Reason for Recall

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Product Description

Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)

Distribution Pattern

US Nationwide 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 →