Stryker Sustainability Solutions: Device Recall

Recall Details

Recall Number

Z-0490-2026

Classification

Class II

Product Type

Device

Recalling Firm

Stryker Sustainability Solutions

Status

Ongoing

Date Initiated

09/24/2025

Location

Tempe, AZ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

22, 476 units

Reason for Recall

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

Product Description

HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY

Distribution Pattern

US Nationwide distribution and OUS (foreign) to country of: Canada.

Other Recalls by Stryker Sustainability Solutions

• Class II: Risk 07/02/2024
  Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
• Class II: Risk 05/31/2024
  Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
• Class II: Risk 05/10/2024
  Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

View all recalls by Stryker Sustainability Solutions →