Medical Device Hookup Instructions Contain Errors Affecting Endoscope Disinfection
Steris Corporation recalls certain automated endoscope reprocessor hookups due to incorrect instructions in product documentation. Improper hookup connection could prevent proper endoscope disinfection, risking patient infection.
What this means for you
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: FDA Class II recall with no reported illnesses or infections. The hazard—improper endoscope disinfection—is significant and could lead to patient contamination or infection, but no actual cases are documented. This qualifies as a risk-of-harm product without confirmed injury.
Plain-English summary
Steris Corporation is recalling certain automated endoscope reprocessor hookups (Model DSD-110-HU0163) due to incorrect instructions. The Instructions for Use (IFU) and the online reference system called Hookup Lookup (HULU) contain errors in how hookups should be connected and what parameters should be used.
If healthcare personnel use an incorrect hookup connection or parameter setting, the endoscope may not be properly disinfected. This creates a risk of patient exposure to contamination or infection.
The recall affects 1,082 units distributed worldwide, including across the United States and 29 other countries. Affected lot numbers are identified in the FDA recall notice.
Healthcare facilities and endoscopy centers using these hookups should contact Steris Corporation for corrected procedure guidance and verification of their documentation to ensure proper endoscope disinfection is being performed.
The recalled product
- Product
- 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 flexib
- Manufacturer
- Steris Corporation
- Hazard
- improper-disinfection
- infection-risk
- contamination-risk
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 00677964064623
- Lot Numbers 403142
- 403490
- 406396
- 415623
- 420136
- 431090
- 434467
- 439578
- 440970
- 449929
- 453997
- 456734
- 457984
- 460959
- 465381
- 476333
- 480953
- 485936
- 502488
Distribution
Distributed nationwide across the United States.
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