DrugJan 11, 2017
Tri-Coast Pharmacy Myers Cocktail #5 recall — FDA D-0275-2017
Lack of Assurance of Sterility
Class IIFDA: OngoingTri-Coast Pharmacy
Latest records
Latest recalls — page 1724
The newest recall records with useful source details are listed here.
DrugJan 11, 2017
Tri-Coast Pharmacy IV Cocktail #2 recall — FDA D-0265-2017
Lack of Assurance of Sterility
Class IIFDA: OngoingTri-Coast Pharmacy
DrugJan 11, 2017
Tri-Coast Pharmacy Ultra Amino Energy Cocktail (Methionine recall — FDA D-0322-2017
Lack of Assurance of Sterility
Class IIFDA: OngoingTri-Coast Pharmacy
DrugJan 11, 2017
Tri-Coast Pharmacy Ultra Amino Blend recall — FDA D-0321-2017
Lack of Assurance of Sterility
Class IIFDA: OngoingTri-Coast Pharmacy
DrugJan 11, 2017
Tri-Coast Pharmacy Lipotropic recall — FDA D-0270-2017
Lack of Assurance of Sterility
Class IIFDA: OngoingTri-Coast Pharmacy
Medical DeviceJan 4, 2017
GE Healthcare Prestige II recall — FDA Z-0911-2017
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJan 4, 2017
ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN recall — FDA Z-0903-2017
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the…
Class IIFDA: TerminatedORTHO-CLINICAL DIAGNOSTICS
Medical DeviceJan 4, 2017
Sterling Diagnostics, Inc recall — FDA Z-0933-2017
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class IIIFDA: TerminatedSterling Diagnostics, Inc.
Medical DeviceJan 4, 2017
Siemens Medical Solutions USA SOMATOM Scope, Computed tomography x-ray system recall — FDA Z-0919-2017
Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJan 4, 2017
Sterling Diagnostics Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC recall — FDA Z-0936-2017
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class IIIFDA: TerminatedSterling Diagnostics, Inc.
Medical DeviceJan 4, 2017
Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the recall — FDA Z-0935-2017
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class IIIFDA: TerminatedSterling Diagnostics, Inc.
Medical DeviceJan 4, 2017
Siemens Medical Solutions USA SOMATOM Scope Power, Computed tomography x-ray system recall — FDA Z-0920-2017
Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJan 4, 2017
Neusoft Medical Systems Co NeuViz 128 Multi-slice CT Scanner System with software version recall — FDA Z-0876-2017
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down…
Class IIFDA: TerminatedNeusoft Medical Systems Co., Ltd.
Medical DeviceJan 4, 2017
Shimadzu X-ray TV System, Catalog No recall — FDA Z-0917-2017
Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.
Class IIFDA: TerminatedShimadzu Medical Systems
Medical DeviceJan 4, 2017
GE Healthcare SFX recall — FDA Z-0916-2017
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJan 4, 2017
GE Healthcare ADVANTX LCN+ recall — FDA Z-0907-2017
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJan 4, 2017
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the recall — FDA Z-0930-2017
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class IIIFDA: TerminatedSterling Diagnostics, Inc.
Medical DeviceJan 4, 2017
GE Healthcare ADVANTX LCLP+ recall — FDA Z-0906-2017
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJan 4, 2017
Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the recall — FDA Z-0932-2017
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class IIIFDA: TerminatedSterling Diagnostics, Inc.
Medical DeviceJan 4, 2017
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC recall — FDA Z-0937-2017
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class IIIFDA: TerminatedSterling Diagnostics, Inc.
Medical DeviceJan 4, 2017
Sterling Diagnostics Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in recall — FDA Z-0929-2017
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class IIIFDA: TerminatedSterling Diagnostics, Inc.
Medical DeviceJan 4, 2017
Medtronic Xomed NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced recall — FDA Z-0901-2017
Wire in tubing can become exposed, posing potential harm to the intubated patient.
Class IIFDA: TerminatedMedtronic Xomed, Inc.
Medical DeviceJan 4, 2017
Shimadzu X-ray High Voltage Generator Model No recall — FDA Z-0918-2017
Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
Class IIFDA: TerminatedShimadzu Medical Systems
Medical DeviceJan 4, 2017
GE Healthcare Legacy recall — FDA Z-0909-2017
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova…
Class IIFDA: TerminatedGE Healthcare, LLC
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