Home / Recalls / Steris Corporation / Z-2538-2024

Z-2538-2024 Class II Ongoing

Recalled by Steris Corporation — Mentor, OH

FDA device recall Z-2538-2024 was initiated by Steris Corporation on June 13, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 6.

Recall Details

Product Type
Devices
Report Date
August 14, 2024
Initiation Date
June 13, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6

Product Description

Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.

Reason for Recall

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

Distribution Pattern

Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Malaysia, Qatar, Ukraine, United Arab Emirates, Nicaragua, and Nigeria.

Code Information

Lot Code: UDI-DI 00677964086878;Lot Numbers 438165, 472172, 559354, 587523

Other recalls by Steris Corporation

  • Z-2448-2026 Class II — HarmonyAIR A-Series Surgical Lighting System (May 15, 2026)
  • Z-2449-2026 Class II — HarmonyAIR A-Series Surgical Lighting System (May 15, 2026)
  • Z-2450-2026 Class II — ALYON Surgical Lighting System (May 15, 2026)
  • Z-0910-2026 Class II — AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Descr (November 19, 2025)
  • Z-0909-2026 Class II — AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Descri (November 19, 2025)
  • Z-2178-2025 Class II — Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Ligh (June 23, 2025)
  • Z-2177-2025 Class II — Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Ligh (June 23, 2025)
  • Z-1361-2026 Class II — Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0- (May 23, 2025)
  • Z-2537-2024 Class II — Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide (June 13, 2024)
  • Z-2536-2024 Class II — Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide th (June 13, 2024)

FDA data resources