Medical DeviceNov 7, 2018
CMP Industries Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 recall — FDA Z-0293-2019
Foreign material in product
Class IIFDA: TerminatedCMP Industries, LLC
Latest records
Latest recalls — page 1325
The newest recall records with useful source details are listed here.
Medical DeviceNov 7, 2018
Arrow AGB + Multi-Lumen CVC Kit, Cat recall — FDA Z-0282-2019
The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 12mm x 40mm recall — FDA Z-0325-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Baxter Healthcare EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used recall — FDA Z-0366-2019
Potential ability to leak once used for compounding.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 12mm x 40mm recall — FDA Z-0338-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Philips Medical Systems (Cleveland) Ingenuity Core 128 (Model No. 728323), Software version recall — FDA Z-0310-2019
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 5mm x 80mm recall — FDA Z-0350-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 518 Biliary Stent 4mm x 80mm recall — FDA Z-0318-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Leica Microsystems BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use recall — FDA Z-0281-2019
The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.
Class IIFDA: TerminatedLeica Microsystems, Inc.
Medical DeviceNov 7, 2018
Siemens Medical Solutions USA Ysio MAX (model number 10762470) with Tube stand 3D V recall — FDA Z-0300-2019
In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceNov 7, 2018
Philips Medical Systems (Cleveland) Vereos PET/CT, Software version 2.0.1 recall — FDA Z-0302-2019
Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceNov 7, 2018
Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020 recall — FDA Z-0289-2019
The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a…
Class IIFDA: TerminatedStryker GmbH
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 14mm x 40mm recall — FDA Z-0342-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 5mm x 80mm recall — FDA Z-0336-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 518 Biliary Stent 4mm x 20mm recall — FDA Z-0314-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 5mm x 20mm recall — FDA Z-0332-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 518 Biliary Stent 4mm x 40mm recall — FDA Z-0316-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 12mm x 30mm recall — FDA Z-0337-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Baxter Healthcare EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used recall — FDA Z-0365-2019
Potential ability to leak once used for compounding.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 12mm x 80mm recall — FDA Z-0340-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Baxter Healthcare EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used recall — FDA Z-0367-2019
Potential ability to leak once used for compounding.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceNov 7, 2018
Philips Medical Systems (Cleveland) Ingenuity CT (Model No. 728326), software version 4.1.6 recall — FDA Z-0308-2019
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceNov 7, 2018
Baxter Healthcare EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used recall — FDA Z-0363-2019
Potential ability to leak once used for compounding.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 14mm x 30mm recall — FDA Z-0328-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
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