Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups… — Class II medical device recall Z-2537-2024
Ongoing recall by Steris Corporation, reported 2024-08-14, distributed nationwide. IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU)
| Recall number | Z-2537-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2024-06-13 |
| Classified | 2024-08-08 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AU, BE, CA, CZ, DE, DK, ES, IL, IT, JO, KW, MY, NG, NI, QA, SA, SI, SK, UA, ZA |
| Quantity | 129 |
| UPC / GTIN / UDI-DI | 00677964086885 |
| Lot numbers | 415308, 415665, 422921, 456865, 458947, 461749, 463591, 465821, 467121, 467705, 468813, 480858, 484468, 513285, 517588, 533998, 544724, 585095, 617851 |
| Model numbers | 2-8-540HAN |
Product
Hookup Model/Catalog Number: 2-8-540HAN 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2537-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.