Z-2536-2024Class II

Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage...

Name: Z-2536-2024 Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage...
Creator: Steris Corporation
Published: 2024-06-13
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2024-06-13 / Open, Classified / root cause: labeling and UDI

FDA source

Steris Corporation began a recall of Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and... on 2024-06-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2536-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-13
Posted: 2024-08-08
Recalling firm: STERIS Corporation
Product: 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.
Product code: FEB Accessories, Cleaning, For Endoscope
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
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Steris issued Urgent Medical Device Correction letter on 7/10 via FedEx mail. Letter states reason for recall, health risk and action to take: User Action Please ensure the following steps are completed: 1.Locate and destroy your IFU(s) relative to the hookup(s) affected by this recall. 2.Complete the Medical Device Recall Response Form included with this letter. 3.Return the completed Response Form via email to: [email protected] or via fax to 440-392-8963. As you are familiar, users have the ability to update hookup and parameter set settings in the Advantage AERs to correspond with your inventory of endoscopes. For your convenience, we have included an excerpt from the Operator Manual (Advantage Plus Pass-Thru, pages 138-140, and Advantage Plus, page 72) of the instructions on how to make these updates (see Attachment A or B, as applicable). Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact your local STERIS Representative or STERIS Technical Support at 800-548-4873 or 800-444-4729.
Quantity in commerce: 37
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2536-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2536-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08
Z-2537-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08
Z-2538-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08
Z-2539-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08

Product code FEB

K102996Class IIMedivators Advantage Plus Endoscope ReprocessorMedivators Reprocessing Systems / cleared 2011-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)