U.S. Recalls in August 2019

August 2019 recalls — page 7

These records include useful source details for the selected month.

2019 archive →

Medical DeviceAug 21, 2019

Degania Silicone Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar recall — FDA Z-2265-2019

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…

Class IIFDA: TerminatedDegania Silicone, Ltd.

Medical DeviceAug 21, 2019

Degania Silicone Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar recall — FDA Z-2264-2019

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…

Class IIFDA: TerminatedDegania Silicone, Ltd.

Medical DeviceAug 21, 2019

Siemens Medical Solutions USA SOMATOM Definition AS, Model Number 8098027 - Product Usage recall — FDA Z-2268-2019

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceAug 21, 2019

BioPro Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro recall — FDA Z-2249-2019

Manufacturing flaw in the sterile barrier system

Class IIFDA: TerminatedBioPro, Inc.

Medical DeviceAug 21, 2019

Fenwal Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage recall — FDA Z-2065-2019

The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and…

Class IFDA: TerminatedFenwal Inc.

Medical DeviceAug 21, 2019

BioPro Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro recall — FDA Z-2250-2019

Manufacturing flaw in the sterile barrier system

Class IIFDA: TerminatedBioPro, Inc.

Medical DeviceAug 21, 2019

BioPro K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to recall — FDA Z-2245-2019

Manufacturing flaw in the sterile barrier system

Class IIFDA: TerminatedBioPro, Inc.

Medical DeviceAug 21, 2019

BioPro Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro recall — FDA Z-2257-2019

Manufacturing flaw in the sterile barrier system

Class IIFDA: TerminatedBioPro, Inc.

FoodAug 21, 2019

Kerry BATTER G3665, Item Number G3665.49, Net Wt recall — FDA F-2049-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Hot & Spicy Batter NPHO, Item Number 30753342.49, Net Wt recall — FDA F-2046-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Pork Fritter Breader, Item Number 30753212.49, Net Wt recall — FDA F-2025-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Breader W/Soy, Item Number 30753180.49, Net Wt recall — FDA F-2007-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry CKN Tender Batter/Breader, Item Number 30753269.43, Net Wt recall — FDA F-2037-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Amys Kitchen Amy's Bowls - Broccoli & Cheddar Bake recall — FDA F-2055-2019

Consumer complaints of black plastic found in product.

Class IIFDA: TerminatedAmys Kitchen Inc.

FoodAug 21, 2019

Kerry Batter Mix, Item Number 30753182.49, Net Wt recall — FDA F-2008-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Breader, Item Number 30753152.49, Net Wt recall — FDA F-2000-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Cajun Catfish Breader, Item Number 30753193.49, Net Wt recall — FDA F-2018-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Breader, Item Number 30753219.49, Net Wt recall — FDA F-2028-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Ultimate Batter/Breader, Item Number 30753158.49, Net Wt recall — FDA F-2005-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

The Cookie Dough Cafe - Chocolate chip chilled gourmet edible recall — FDA F-1995-2019

Undeclared peanuts

Class IFDA: TerminatedThe Cookie Dough Cafe

FoodAug 21, 2019

Kerry Homestyle Breader, Item Number 30753347.49, Net Wt recall — FDA F-2047-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Batter Mix, Item Number 30753149.49, Net Wt recall — FDA F-1997-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Batter Mix, Item Number 30753221.49, Net Wt recall — FDA F-2030-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

FoodAug 21, 2019

Kerry Spicy Breader, Item Number 30753198.49, Net Wt recall — FDA F-2021-2019

Product contains foreign material (nylon string)

Class IIFDA: TerminatedKerry, Inc.

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.

U.S. Recalls — August 2019

August 2019 recalls — page 7

How to use this monthly recall archive