DrugFeb 1, 2017
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 recall — FDA D-0445-2017
Failed Dissolution Specifications; 18 month stability time point
Class IIIFDA: TerminatedSun Pharmaceutical Industries, Inc.
Latest records
Latest recalls — page 1710
The newest recall records with useful source details are listed here.
DrugFeb 1, 2017
Mylan LLC Temozolomide Capsules, 100 mg recall — FDA D-0441-2017
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class IIFDA: TerminatedMylan LLC.
DrugFeb 1, 2017
Cambrex Charles City Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc recall — FDA D-0447-2017
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class IIFDA: TerminatedCambrex Charles City Inc.
Medical DeviceJan 25, 2017
Merge Cardio software recall — FDA Z-1046-2017
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceJan 25, 2017
Fresenius 2008K Series : Hemodialysis System recall — FDA Z-1027-2017
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed…
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
Medical DeviceJan 25, 2017
Exactech Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte recall — FDA Z-1030-2017
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceJan 25, 2017
Elekta Monaco RTP System. Used to make treatment plans for patients with prescriptions for recall — FDA Z-1044-2017
Incorrect dose after editing beam number an wedge angle.
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceJan 25, 2017
BARD PERIPHERAL VASCULAR Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F recall — FDA Z-0970-2017
Complaints of sheath separation, kinking, and/or tip damage during use.
Class IFDA: TerminatedBARD PERIPHERAL VASCULAR, Inc.
Medical DeviceJan 25, 2017
Ultradent Products NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are recall — FDA Z-1034-2017
Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that…
Class IIFDA: TerminatedUltradent Products, Inc.
Medical DeviceJan 25, 2017
The Binding Site Group Freelite Human Lambda Free Kit for use on SPAPLUS Product Code recall — FDA Z-1053-2017
A change in the calibration curve causing an increase in false prozone flags.
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceJan 25, 2017
Endologix AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V recall — FDA Z-1048-2017
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Class IIFDA: TerminatedEndologix
Medical DeviceJan 25, 2017
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only recall — FDA Z-1041-2017
Lack of 510k clearance for design modification.
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceJan 25, 2017
CareFusion 303 Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and recall — FDA Z-0950-2017
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
Class IFDA: TerminatedCareFusion 303, Inc.
Medical DeviceJan 25, 2017
Meridian Bioscience PREMIER EHEC and PREMIER EHEC Bulk recall — FDA Z-1033-2017
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Class IIFDA: TerminatedMeridian Bioscience Inc.
Medical DeviceJan 25, 2017
Endologix AFX Endovascular AAA System, Endoleak Type IIIB recall — FDA Z-1038-2017
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Class IIFDA: TerminatedEndologix
Medical DeviceJan 25, 2017
BARD PERIPHERAL VASCULAR Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo recall — FDA Z-0968-2017
Complaints of sheath separation, kinking, and/or tip damage during use.
Class IFDA: TerminatedBARD PERIPHERAL VASCULAR, Inc.
Medical DeviceJan 25, 2017
BARD PERIPHERAL VASCULAR Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product recall — FDA Z-0969-2017
Complaints of sheath separation, kinking, and/or tip damage during use.
Class IFDA: TerminatedBARD PERIPHERAL VASCULAR, Inc.
Medical DeviceJan 25, 2017
Zimmer Biomet Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL recall — FDA Z-1025-2017
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJan 25, 2017
Beckman Coulter AutoMate 2500 Family Catalog No recall — FDA Z-1040-2017
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Class IIIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceJan 25, 2017
BioMerieux SA MagSIL recall — FDA Z-0976-2017
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall…
Class IFDA: TerminatedBioMerieux SA
Medical DeviceJan 25, 2017
Endologix AFX Endovascular AAA System, Endoleak Type IIIA recall — FDA Z-1035-2017
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
Class IIFDA: TerminatedEndologix
Medical DeviceJan 25, 2017
Exactech Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 recall — FDA Z-1032-2017
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceJan 25, 2017
Endologix AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX recall — FDA Z-1047-2017
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Class IIFDA: TerminatedEndologix
Medical DeviceJan 25, 2017
Fresenius 2008T Series Hemodialysis System recall — FDA Z-1026-2017
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed…
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
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