FDANovember 13, 2023device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
steris
UPCs
00677964045165
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAALYON Surgical Lighting System2026-05-15
- FDAHarmonyAIR A-Series Surgical Lighting System2026-05-15
- FDAHarmonyAIR A-Series Surgical Lighting System2026-05-15
- FDAAMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (...2025-11-19
- FDAAMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (...2025-11-19
- FDADual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems2025-06-23
- FDADual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems2025-06-23
- FDABarco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H2025-05-23
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