Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1711

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

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.

Medical DeviceJan 25, 2017

The Binding Site Group Optilite Freelite Lambda Free Kit Product Code: LK018.OPT recall — FDA Z-1043-2017

Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch…

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

Medical DeviceJan 25, 2017

Endologix AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and recall — FDA Z-1054-2017

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

Endologix AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and recall — FDA Z-1039-2017

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

Exactech AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm recall — FDA Z-1031-2017

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

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx recall — FDA Z-1042-2017

Lack of 510k clearance for design modification.

Class IIFDA: OngoingSmith & Nephew, Inc.

Medical DeviceJan 25, 2017

BioMerieux SA NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product recall — FDA Z-0977-2017

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

Medacta International SA, M.U.S.T recall — FDA Z-1023-2017

Damaged packaging, lack of sterility assurance

Class IIFDA: TerminatedMedacta Usa Inc.

Medical DeviceJan 25, 2017

Baxter Healthcare APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in recall — FDA Z-1056-2017

Customer complaints received for the presence of leaks

Class IIFDA: TerminatedBaxter Healthcare Corporation

Medical DeviceJan 25, 2017

The Binding Site Group Optilite Analyser, Product Code: IE700 Product Usage: The Thermo recall — FDA Z-1018-2017

Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

Medical DeviceJan 25, 2017

Fresenius 2008K@home Series : Hemodialysis System recall — FDA Z-1029-2017

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

The Binding Site Group Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in recall — FDA Z-1050-2017

Calibration curve activity has increased over time in the kit lots listed.

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

Medical DeviceJan 25, 2017

Endologix AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and recall — FDA Z-1037-2017

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Class IIFDA: TerminatedEndologix

FoodJan 25, 2017

Aspen Hills GMO Free Brownie Dough 04-377, NET WT recall — FDA F-1323-2017

Product potentially contaminated with Listeria monocytogenes

Class IFDA: TerminatedAspen Hills, Inc.

FoodJan 25, 2017

Aspen Hills GMO Free Cookie Dough 03-377, NET WT recall — FDA F-1327-2017

Product potentially contaminated with Listeria monocytogenes

Class IFDA: TerminatedAspen Hills, Inc.

FoodJan 25, 2017

Dieffenbach's Sour Cream and Onion Kettle Chips 9 oz recall — FDA F-1265-2017

Womelsdorf, PA - Dieffenbach's Potato Chips, Inc. is issuing a voluntary recall for our Sour Cream & Onion Kettle Chips due to information they received from their seasoning supplier that…

Class IIFDA: TerminatedDieffenbach's Potato Chips, Inc.

FoodJan 25, 2017

Aspen Hills Pink Sugar Cookie Dough 05-599, NET WT recall — FDA F-1326-2017

Product potentially contaminated with Listeria monocytogenes

Class IFDA: TerminatedAspen Hills, Inc.

FoodJan 25, 2017

Bakers Of Paris Croissant:: sold in self serve cases and 4 pack clamshell recall — FDA F-1283-2017

Labeling for Croissants sold in Northern CA fails to declare egg in the ingredients list or allergen information. The croissants are manufactured with an egg wash.

Class IFDA: TerminatedBakers Of Paris, Inc.

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