Steris Hookup Model 2-8-540 Documentation Error Risks Improper Endoscope Disinfection
Steris Hookup Model 2-8-540 instructions were incorrectly documented, potentially preventing proper endoscope disinfection and risking patient infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—improper endoscope disinfection could lead to patient infection—but no actual infections have been reported. Per the severity rubric, this qualifies as High (3): a risk-of-harm medical product where injury has not yet been reported.
Plain-English summary
Steris Corporation is recalling Hookup Model 2-8-540 components (37 units) that serve as interfaces between Advantage Plus Automated Endoscope Reprocessors and endoscopes. These hookups allow disinfectant liquids from the reprocessor to contact and high-level disinfect the channels of flexible endoscopes.
The Instructions for Use (IFU) for these hookups were incorrectly reflected in product documentation and the online reference system called Hookup Lookup (HULU). This means users may inadvertently select an incorrect hookup connection and/or parameter set based on the incorrect instructions.
If an incorrect hookup connection or parameter set is used, the endoscope may not be properly disinfected by the reprocessor. This presents a risk of patient contamination or infection. The affected product is distributed worldwide, including the United States and 30 additional countries.
Affected lot numbers include 404360, 415307, 421967, 423540, 425801, 427239, 435309, 436068, 447102, 516866, 523989, 539379, 540599, 542619, 544723, 550675, 554204, 560426, 587537, 588583, 594221, 604965, and 61450 (UDI-DI 00677964091223).
The recalled product
- 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…
- Manufacturer
- Steris Corporation
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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