Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1705

The newest recall records with useful source details are listed here.

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

Medical DeviceJan 25, 2017

DICOM GRID Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number recall — FDA Z-1045-2017

A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

Class IIFDA: TerminatedDICOM GRID Inc.

Medical DeviceJan 25, 2017

Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is recall — FDA Z-1051-2017

The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.

Class IIFDA: TerminatedGreat Basin Scientific, Inc.

Medical DeviceJan 25, 2017

Fresenius 2008K2 Series : Hemodialysis System recall — FDA Z-1028-2017

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

Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound recall — FDA Z-1052-2017

Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting…

Class IIFDA: TerminatedCarestream Health Inc.

Medical DeviceJan 25, 2017

Endologix AFX2 Endovascular AAA System Item No recall — FDA Z-1049-2017

Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

Class IIFDA: TerminatedEndologix

Medical DeviceJan 25, 2017

Zimmer Biomet RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm recall — FDA Z-1024-2017

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

The Binding Site Group Digital RID Plate Reader and Software Product Code: AD400 recall — FDA Z-1055-2017

If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

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