# FDA recall Z-0617-2024

> **Steris Corporation** · Class II · device recall initiated 2023-11-13.

## 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	ASSY, HKUP STORZ 0K  2-8-070	ASSY, HU VISION SCIENCE  2-8-112	ASSY, HOOKUP OLMPUS 1K  2-8-120	ASSY, HOOKUP FUJI 1K  2-8-210	ASSY, HOOK-UP OLYMPUS 2K  2-8-213	ASSY, HOOKUP, OLYMPUS-2K  2-8-218	ASSY HOOKUP OLY 2K  2-8-236	ASSY, HOOKUP FUJINON 2K  2-8-244	ASSY, HOOKUP, STORZ 2K  2-8-245	ASSY, HOOK-UP, STORZ 2K  2-8-246	ASSY, HKUP, PENTAX-2K  2-8-260	ASSY, HOOK-UP WOLF 2-K  2-8-280	ASSY HOOKUP  2-8-312	ASSY, HOOK-UP OLYMPUS-3K  2-8-330	ASSY, HOOK-UP, PENTAX-3K  2-8-332	ASSEMBLY, HOOK-UP, PENTAX  2-8-334	ASSEMBLY, HOOK-UP, PENTAX  2-8-335	ASSY, HOOKUP, OLYMPUS, 3K  2-8-336	ASSY,HKUP FUJI 70 BRONC  2-8-338	ASSY, HU, FUJI BRONCH U/S  2-8-421	ASSY, HOOKUP, FUJIFILM  2-8-428	ASSY, ED-580XX  2-8-431	ASSY, HOOKUP, PENTAX  2

## Reason for recall

Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

## Distribution

Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand

## Key facts

- **Recall number:** Z-0617-2024
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-13
- **Report date:** 2024-01-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0617-2024

## Citation

> AI Analytics. FDA recall Z-0617-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0617-2024. Source: US FDA. Licensed CC0.

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