FDA Device recall Z-2536-2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Repr…
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Repr… by Steris, citing 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 prev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2536-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-13 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Steris |
| Distribution | US |
Product
Hookup Model/Catalog Number: 2-8-540 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
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
Identifiers
| code_info | Lot Code: UDI-DI 00677964091223; Lot Numbers 404360, 415307, 421967, 423540, 425801, 427239, 435309, 436068, 447102, 51…Lot Code: UDI-DI 00677964091223; Lot Numbers 404360, 415307, 421967, 423540, 425801, 427239, 435309, 436068, 447102, 516866, 523989, 539379, 540599, 542619, 544723, 550675, 554204, 560426, 587537, 588583, 594221, 604965, 61450 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2536-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.