Hookup Model/Catalog Number: DSD-110-HU0163 Product Description:… — Class II medical device recall Z-2539-2024
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-2539-2024 |
|---|---|
| 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 | 1,082 |
| UPC / GTIN / UDI-DI | 00677964064623 |
| Lot numbers | 403142, 403490, 406396, 415623, 420136, 431090, 434467, 439578, 440970, 449929, 453997, 456734, 457984, 460959, 465381, 476333, 480953, 485936, 502488, 505441, 515820, 518697, 530332, 542927, 553320, 554244, 555701, 579924, 585282, 589722, 596830, 607311, 608007, 614507, 618935 |
| Model numbers | DSD-110-HU0163 |
Product
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A
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-2539-2024. 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.