FDAMay 6, 2016device
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
What to do
FDA enforcement status: Terminated
Brands named
custom ultrasonicscustom
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- USDA FSISCustom Food Solutions Recalls Ready-To-Eat Frozen Drunken Chicken Product Due to Misbranding and Undeclared Allergens2025-01-22
- FDAJayRobb Vanilla Flavored Egg White Protein Powder. Net Weight 24 oz (1.5 lbs) 680g Dietary Supplement. UPC 6 03907-00462 32023-10-13
- USDA FSISCustom Made Meals, LLC Retira Producto Envuelto En Tocino Con Jalapeño Debido A Un Error De Rotulación Y Un Alérgeno No Declarado2023-09-09
- CPSCCustom Elevator Recalls Residential Elevators Due to Child Entrapment Hazard; Risk of Serious Injury or Death to Young Children; One Death Reported2022-09-29
- FDASermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 750812022-04-05
- FDALL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA2022-04-05
- FDABPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 750812022-04-05
- FDAARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA2022-04-05
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