FDA Device Recalls

Class ITerminated

18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.

Insulet Corporation

The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.

October 17, 2022 · DeviceView details →

Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST

Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST

CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.

Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700

Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

In-Line ventilator adaptor

In-Line ventilator adaptor

Sara Plus Active Floor Lift

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02