Steris recalls Hookup model 2-8-540HAN due to potential incorrect connections causing endoscope disinfection failure and patient infection risk. Affected units have specific lot numbers and were sold with certain catalog numbers.
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
Steris is recalling Hookup model 2-8-540HAN because incorrect connections could prevent proper endoscope disinfection, risking patient contamination. This affects specific lot numbers sold with certain catalog numbers.
The Hookup model may have incorrect connection settings or parameters in its instructions, which could prevent endoscopes from being properly disinfected. This risk leads to potential patient contamination or infection if the endoscope is not cleaned correctly.
Healthcare facilities using this Hookup model for endoscope reprocessing are most at risk. Patients using improperly disinfected endoscopes could face infection.
Check for lot numbers 415308, 415665, 422921, 456865, 458947, 461749, 463591, 465821, 467121, 467705, 468813, 480858, 484468, 513285, 517588, 533998, 544724, 585095, or 617851. The product catalog number is 2-8-540HAN.
Verify your Hookup model has one of the listed lot numbers: 415308, 415665, 422921, 456865, 458947, 461749, 463591, 465821, 467121, 467705, 468813, 480858, 484468, 513285, 517588, 533998, 544724, 585095, or 617851.
The product catalog number is 2-8-540HAN.
Affected lot numbers include 415308, 415665, 422921, 456865, 458947, 461749, 463591, 465821, 467121, 467705, 468813, 480858, 484468, 513285, 517588, 533998, 544724, 585095, and 617851.
Check your Hookup model's lot number against the list of affected lot numbers provided in the recall notice.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-2537-2024 — Steris Steris Hello, I own a Steris that is covered by recall Z-2537-2024 from Steris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.