Steris Corporation: Device Recall

Recall Details

Recall Number

Z-2177-2025

Classification

Class II

Product Type

Device

Recalling Firm

Steris Corporation

Status

Ongoing

Date Initiated

06/23/2025

Location

Mentor, OH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

167 units

Reason for Recall

The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

Product Description

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Distribution Pattern

Worldwide - US Nationwide and Puerto Rico and the country of Canada.

Other Recalls by Steris Corporation

• Class II: Risk 11/19/2025
  Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
• Class II: Risk 11/19/2025
  Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
• Class II: Risk 06/23/2025
  The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
• Class II: Risk 06/13/2024
  IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
• Class II: Risk 06/13/2024
  IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection

View all recalls by Steris Corporation →