Medical DeviceJun 12, 2019
Cook Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 recall — FDA Z-1723-2019
Affected products may have been manufactured with the catheter distal end hole too small
Class IIFDA: TerminatedCook Inc.
June 2019 recalls — page 9
These records include useful source details for the selected month.
Medical DeviceJun 12, 2019
Cook Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 recall — FDA Z-1722-2019
Affected products may have been manufactured with the catheter distal end hole too small
Class IIFDA: TerminatedCook Inc.
Medical DeviceJun 12, 2019
Bio-Rad Laboratories MRSASelect, IVD, REF 63747, containing 20 plates per package recall — FDA Z-1742-2019
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Class IIFDA: TerminatedBio-Rad Laboratories, Inc.
Medical DeviceJun 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG recall — FDA Z-1702-2019
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
OriGen Biomedical ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F recall — FDA Z-1231-2019
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
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an recall — FDA Z-1727-2019
The heated tube sets were consistently leaking and detaching from the cassette.
Class IIFDA: TerminatedStryker Corporation
Medical DeviceJun 12, 2019
Zimmer Biomet Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item recall — FDA Z-1740-2019
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceJun 12, 2019
OMNIlife science OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics recall — FDA Z-1717-2019
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
Class IIFDA: TerminatedOMNIlife science Inc.
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
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.