2019 U.S. Recalls — FDA & NHTSA Archive

Monthly breakdown

2019 recalls by month

Select a month to review the recall records reported during that period.

2019 recalls — page 130

Records are ordered by the best available source date.

Medical DeviceJun 12, 2019

Fresenius Medical Care Renal Therapies Group 2008T BlueStar Machine Software recall — FDA Z-1699-2019

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

Class IIIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC

Medical DeviceJun 12, 2019

OriGen Biomedical ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F recall — FDA Z-1232-2019

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in…

Class IFDA: TerminatedOriGen Biomedical, Inc.

Medical DeviceJun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) recall — FDA Z-1700-2019

Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)

Medical DeviceJun 12, 2019

Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow recall — FDA Z-1726-2019

The heated tube sets were consistently leaking and detaching from the cassette.

Class IIFDA: TerminatedStryker Corporation

Medical DeviceJun 12, 2019

Philips IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other recall — FDA Z-1693-2019

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

Class IIFDA: OngoingPhilips North America, LLC

Medical DeviceJun 12, 2019

Cook Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 recall — FDA Z-1724-2019

Affected products may have been manufactured with the catheter distal end hole too small

Class IIFDA: TerminatedCook Inc.

Medical DeviceJun 12, 2019

Cook Thoracentesis Set, RPN C-THS-850, Order # G03286 recall — FDA Z-1725-2019

Affected products may have been manufactured with the catheter distal end hole too small

Class IIFDA: TerminatedCook Inc.

FoodJun 12, 2019

Icco Cheese Co Gia Russa Whole Grain Italian Unseasoned Bread Crumbs in 10 Oz recall — FDA F-1437-2019

Product contains undeclared Allergens: Walnuts & Pecans

Class IFDA: TerminatedIcco Cheese Co Inc.

FoodJun 12, 2019

Sassy Cow Creamery Art Cream Gluten Free Cookies & Cream ice cream, one pint recall — FDA F-1477-2019

Undeclared Pecan allergen. Bourbon Honey Pecan ice cream was packaged in a container that was labeled as Gluten Free Cookies N Cream and the lid was labeled as Bourbon Honey Pecan.

Class IIFDA: TerminatedSassy Cow Creamery, LLC

FoodJun 12, 2019

Young Ocean frozen, wrapped in plastic liner and packed in styrofoam box recall — FDA F-1482-2019

Young Ocean brand Seasoned Alaskan Pollock Roe is recalled because the label declares Hondashi ingredient but does not declare sub-ingredient bonito and lactose (milk).

Class IIFDA: TerminatedYoung Ocean, Inc.

FoodJun 12, 2019

Topnotch Foods Natural Bread Crumbs: 50 lb recall — FDA F-1433-2019

California Department of Public Health inspection at the facility found undeclared milk (from whey).

Class IFDA: TerminatedTopnotch Foods Inc.

FoodJun 12, 2019

Topnotch Foods Italian Bread Crumbs: 10 lb recall — FDA F-1434-2019

California Department of Public Health inspection at the facility found undeclared soy lecithin.

Class IIFDA: TerminatedTopnotch Foods Inc.

FoodJun 12, 2019

Icco Cheese Co Gia Russa Whole Grain Italian Seasoned Bread Crumbs in 10 Oz recall — FDA F-1438-2019

Product contains undeclared Allergens: Walnuts & Pecans

Class IFDA: TerminatedIcco Cheese Co Inc.

FoodJun 12, 2019

New Seasons Market Bacon Shallot Potato Salad, internal item PLU code 52365, sold recall — FDA F-1436-2019

Bacon Shallot Potato Salad was recalled due to undeclared egg.

Class IFDA: TerminatedNew Seasons Market LLC

FoodJun 12, 2019

Stonyfield Farm Strawberry Banana Smoothie, 3.1oz, 6 pack, UPC Code recall — FDA F-1440-2019

Strawberry Banana Smoothie Drink outside plastic wrap is mislabeled with Very Berry Smoothie label. Individual bottles have the correct labeling.

Class IIFDA: TerminatedStonyfield Farm

VehicleJun 7, 2019

Mazda3 lugs/nuts/bolts/studs recall — NHTSA campaign 19V425000

Mazda North American Operations (Mazda) is recalling certain 2019 Mazda3 vehicles. The lug nuts on all four wheels may loosen, potentially resulting in a wheel detaching from the vehicle.

lugs/nuts/bolts/studsMazda North American Operations

Medical DeviceJun 5, 2019