Use caution Medical device recall · FDA · Published June 13, 2024

Steris Hookup 2-8-540CAS: Risk of Patient Contamination from Incorrect Disinfection

Steris recalls Hookup model 2-8-540CAS due to potential patient contamination from improper endoscope disinfection. Affected units may prevent proper disinfection, risking infection.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2538-2024Medical device Steris ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmSteris Corporation5960 Heisley Rd · Mentor, OH 44060-1834

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/54871-steris-hookup-2-8-540cas-risk-of-patient-contamination-from.

Source Summary by GovInfoNow · govinfonow.com/recall/54871-steris-hookup-2-8-540cas-risk-of-patient-contamination-from · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2538-2024

Cite this page

“Steris Hookup 2-8-540CAS: Risk of Patient Contamination from Incorrect Disinfection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54871-steris-hookup-2-8-540cas-risk-of-patient-contamination-from. Based on FDA recall #Z-2538-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2538-2024%22&limit=1).

The FDA announced on June 13, 2024, that Steris Corporation is recalling Hookup Model/Catalog Number 2-8-540CAS. Incorrect interface documentation may prevent proper endoscope disinfection, posing a risk of patient contamination or infection.

How to tell if you have it

Brand: Steris
Model/Catalog Number: 2-8-540CAS
Lot Code: UDI-DI 00677964086878
Lot Numbers: 438165, 472172, 559354, 587523

The hazard

The recall involves incorrect hookup interface documentation (IFU) and online reference system data. Use of incorrect connections or parameters may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection.

Context

GovInfoNow's records show Steris Corporation has 29 other recalls on record since June 15, 2017. Other recent recalls include Steris HarmonyAIR A-Series Surgical Lights (May 15, 2026) and Steris AMSCO 7052HP Washer/Disinfector (Nov. 19, 2025). Other recent recalls of similar products include Medline Convenience Kits (Jan. 7, 2026), Olympus EVIS EXERA III Duodenoscope (Oct. 14, 2025), and another Medline Convenience Kits recall (Jan. 7, 2026).

How to tell if you have this one

Check for the model number 2-8-540CAS on the Hookup. Affected units were sold with lot numbers 438165, 472172, 559354, or 587523.

Brand
Steris
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Malaysia, Qatar, Ukraine, United Arab Emirates, Nicaragua, and Nigeria.

Recall number	Product, codes & lots	Quantity
Z-2536-2024	Hookup Model/Catalog Number: 2-8-540 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.; Lot Code: UDI-DI 00677964091223; Lot Numbers 404360, 415307, 421967, 423540, 425801, 427239, 435309, 436068, 447102, 516866, 523989, 539379, 540599, 542619, 544723, 550675, 554204, 560426, 587537, 588583, 594221, 604965, 61450	37
Z-2537-2024	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.; Lot Code: UDI-DI 00677964086885; Lot Numbers 415308, 415665, 422921, 456865, 458947, 461749, 463591, 465821, 467121, 467705, 468813, 480858, 484468, 513285, 517588, 533998, 544724, 585095, 617851	129
Z-2538-2024	Hookup Model/Catalog Number: 2-8-540CAS 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.; Lot Code: UDI-DI 00677964086878;Lot Numbers 438165, 472172, 559354, 587523	6
Z-2539-2024	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; Lot Code: 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	1082

Based on the official FDA remedy

What to do — step by step

Check Connection Settings
Verify that the Hookup is connected correctly with the Advantage Plus reprocessor to ensure proper endoscope disinfection.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jun 13, 2024Firm started the recall
Aug 8, 2024FDA classified it Class II
Aug 14, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Steris recalls

Link to this recall

<a href="https://govinfonow.com/recall/54871-steris-hookup-2-8-540cas-risk-of-patient-contamination-from">Steris Hookup 2-8-540CAS: Risk of Patient Contamination from Incorrect Disinfection (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2538-2024 (June 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2538-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.