Steris recalls Hookup model 2-8-540CAS due to potential patient contamination from improper endoscope disinfection. Affected units may prevent proper disinfection, risking infection.
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 2-8-540CAS because incorrect connections could prevent endoscopes from being properly disinfected, risking patient contamination. This is serious for medical facilities using endoscopes.
The Hookup model may have incorrect connection settings, which can prevent endoscopes from being properly disinfected. This risk of improper disinfection could lead to patient infections if the equipment is used without the correct settings.
Medical facilities that use the Steris Hookup 2-8-540CAS with Advantage Plus endoscope reprocessors are most at risk. Patients using endoscopes with improperly disinfected equipment could be contaminated.
Check for the model number 2-8-540CAS on the Hookup. Affected units were sold with lot numbers 438165, 472172, 559354, or 587523.
Verify that the Hookup is connected correctly with the Advantage Plus reprocessor to ensure proper endoscope disinfection.
The recall indicates that incorrect connections may prevent proper disinfection, so it's not safe to use without checking the connection settings.
The official notice does not specify a remedy, so you should check connection settings to ensure proper disinfection.
Look for the model number 2-8-540CAS and lot numbers 438165, 472172, 559354, or 587523.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-2538-2024 — Steris Steris Hello, I own a Steris that is covered by recall Z-2538-2024 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.
