Steris recalls Hookup Model 2-8-540 for potential patient contamination if endoscopes aren't properly disinfected due to incorrect hookup connections. Affected units include specific lot 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 2-8-540 because incorrect connections or settings could prevent endoscopes from being properly disinfected, risking patient contamination. This is serious for medical facilities using endoscopes.
The hookup's instructions might be incorrect, leading to improper endoscope disinfection. If the connection or settings are wrong, the endoscope could become contaminated and pose a risk of infection to patients.
Medical facilities that use Steris Advantage Plus endoscope reprocessors with this specific hookup model are most at risk. Patients could be contaminated if endoscopes aren't properly disinfected.
Check for the model number 2-8-540 on the hookup. Affected units have specific lot numbers listed in the recall notice, including 404360, 415307, and other numbers provided in the record.
Check the model number on the hookup to confirm it is 2-8-540.
Reach out to Steris directly for assistance with the recall and proper disinfection procedures.
The recalled model number is 2-8-540.
This recall affects endoscopes used with Steris Advantage Plus endoscope reprocessors that require the Hookup Model 2-8-540.
Check the model number on the hookup and compare it to 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-2536-2024 — Steris Steris Hello, I own a Steris that is covered by recall Z-2536-2024 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.