Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1706

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

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.

FoodJan 25, 2017

American Instants Spicy Chai Latte 50 lb recall — FDA F-1277-2017

America Instant Inc. is recalling various chai tea products due to buttermilk and milk products that may be contaminated with Salmonella and were provided by another supplier.

Class IFDA: TerminatedAmerican Instants, Inc.

FoodJan 25, 2017

Great Northern Bakehouse Inc. dba Le Petit Outre NY Rye Deli Loaf, each loaf has a net wt recall — FDA F-1259-2017

NY Rye Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.

Class IIFDA: TerminatedGreat Northern Bakehouse Inc. dba Le Petit Outre

FoodJan 25, 2017

Hungry Heart Bakery Chocolate Chip Sea Salt Cookies, Hungry Heart brand recall — FDA F-1272-2017

Chocolate Chip Sea Salt Cookies are recalled due to undeclared wheat and soy (from the pan release agent spray)

Class IIFDA: TerminatedHungry Heart Bakery

FoodJan 25, 2017

Aspen Hills Chocolate Chip Cookie Dough in the following packaging recall — FDA F-1313-2017

Product potentially contaminated with Listeria monocytogenes

Class IFDA: TerminatedAspen Hills, Inc.

FoodJan 25, 2017

Aspen Hills Chocolate Chip Cookie Dough 03-301 NET WT recall — FDA F-1319-2017

Product potentially contaminated with Listeria monocytogenes

Class IFDA: TerminatedAspen Hills, Inc.

FoodJan 25, 2017

High Liner Foods FPI Breaded Round Shrimp Tail-On 1001990, 12-8 oz recall — FDA F-1295-2017

Product contains undeclared milk and eggs

Class IFDA: TerminatedHigh Liner Foods, Inc.

FoodJan 25, 2017

Great Northern Bakehouse Inc. dba Le Petit Outre Daily Wheat Bread, each loaf has a net wt recall — FDA F-1255-2017

Daily Wheat Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.

Class IIFDA: TerminatedGreat Northern Bakehouse Inc. dba Le Petit Outre

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