Medivators Advantage Endoscope Hookup Accessories Recalled for Illegible Identification Labels
Steris Corporation recalls Medivators Advantage endoscope hookup accessories because identification labels become illegible as ink degrades, potentially preventing proper hookup identification and delaying patient procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries, illnesses, or hospitalizations. The hazard is labeling degradation causing illegible identification markings, fitting the rubric criterion for Score 2 (Moderate): minor labeling errors without reported patient harm.
Plain-English summary
Steris Corporation is recalling hookup accessories used with Medivators Advantage Plus and Advantage Plus Pass Thru automated endoscope reprocessors. Approximately 2,545 units were distributed domestically across the United States, and 992 units were distributed internationally to Australia, Canada, China, Hong Kong, Italy, Malaysia, Netherlands, New Zealand, Singapore, and Thailand. The affected products were distributed between July 17 and September 27, 2023.
The identification labels on these hookup accessories can become illegible over time because the label ink degrades and comes off. When labels become illegible, healthcare workers cannot effectively identify which hookup is being used with the equipment, potentially resulting in postponement of patient procedures.
Facilities with these recalled hookup accessories are affected by this labeling issue. Healthcare providers using these products should contact Steris Corporation for guidance on how to address the illegible labeling.
The recalled product
- Product
- Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 AS
- Manufacturer
- Steris Corporation
- Hazard
- illegible-labeling
- label-degradation
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)
- Products distributed between July 17 - September 27
- HOOK-UP
- OLYMPUS 00677964068478 2-8-014 HOOKUP
- OPTIM LT 00677964095177 2-8-030 ASSY
- HOOKUP
- PENTAX-0K 00677964071348 2-8-040 ASSY
- HKUP STORZ 0K 00677964072284 2-8-070 ASSY
- HU VISION SCIENCE 00677964094637 2-8-112 ASSY
- HOOKUP OLMPUS 1K 00677964071300 2-8-120 ASSY
- HOOKUP FUJI 1K 00677964102080 2-8-210 ASSY
- HOOK-UP OLYMPUS 2K 00677964068485 2-8-213 ASSY
- OLYMPUS-2K 00677964070648 2-8-218 ASSY HOOKUP OLY 2K 00677964072369 2-8-236 ASSY
- HOOKUP FUJINON 2K 00677964072376 2-8-244 ASSY
- STORZ 2K 00677964071836 2-8-245 ASSY
- STORZ 2K 00677964071195 2-8-246 ASSY
- HKUP
- PENTAX-2K 00677964084058 2-8-260 ASSY
- HOOK-UP WOLF 2-K 00677964105951 2-8-280 ASSY HOOKUP 00677964073069 2-8-312 ASSY
- HOOK-UP OLYMPUS-3K 00677964074400 2-8-330 ASSY
- PENTAX-3K 00677964073816 2-8-332 ASSEMBLY
Distribution
Distributed nationwide across the United States.
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