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 CMC7AFLF, Gram Negative IVD AST

regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit

regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit

Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST

regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit

regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit

regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit

regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit

regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit

regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit

regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit

regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit

¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit

regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit

¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit

Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST

GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001

Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.