Warning
Class II
Capuchino Syrup Cone Cake The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
FDA Recalls
Page 18 of 39 · 1,907 total recalls
Recalls — Page 18
Warning
Class II
Cheesecake de Dulce de Leche Caramel Cheesecake The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Cheesecake de Fresa Strawberry Cheesecake The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Cheesecake de Guava Guava Cheesecake The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Cheesecake de Mango Mango Cheesecake The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Flan Cake Custard Cake The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Jumbo Brazo Gitano Caramelo Jumbo Caramel Roll The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Jumbo Napolitano Jumbo Neapolitan, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Marquesita de Chocolate y Vainilla Delighted Flavored Cakes The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Marquesita de Dulceleche Delighted Flavored Cakes The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Marquesita de Fresa Delighted Flavored Cakes The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Marquesita de Guava Delighted Flavored Cakes The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Marquesita de Mango Delighted Flavored Cakes The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Napolitano Neapolitan The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Rollitos de DulceLeche Caramel Rolls The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Rollitos de Guava Guava Rolls The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Tiramisu Cofee Cake The Original, Net Wt
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Galaxy RG Corp
Warning
Class II
Blackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey instead of Creamed Honey as
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Cinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey instead of Creamed Honey as
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Dark Pecan Creamed Honey/Pecan Creamed Honey 671333101407 * These product labels may also say Whipped Honey instead
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Darkside of the Hive Creamed Honey/Salted Chocolate Creamed Honey 671333101414 *These product labels may also say
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Hatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Hatch Green Chile Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Lemon Creamed Honey
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Natural Creamed Honey
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
Raspberry Creamed Honey 671333101322 ¿ These product labels may also say Whipped Honey instead of Creamed Honey as
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Walker Honey Co
Warning
Class II
LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb) 907 g Manufactured and Distributed by: Lundberg Family
Potential contamination with foreign materials.
Wehah Farms
Warning
Class II
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC
Warning
Class II
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC
Warning
Class II
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC
Warning
Class II
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC
Critical
Class I
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include...
Cook Incorporated
Critical
Class I
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include...
Cook Incorporated
Critical
Class I
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include...
Cook Incorporated
Warning
Class II
One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
Warning
Class II
One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
Warning
Class II
One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
Warning
Class II
One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
Warning
Class II
One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
Warning
Class II
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
Warning
Class II
Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
Warning
Class II
ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep Refrigerated, plastic clamshell, net wt
Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame.
F&S Fresh Foods
Critical
Class I
Black label with blue lettering
product tested positive for Listeria Monocytogenes.
HEMU TRADING INC
Warning
Class II
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
Huons Co.
Warning
Class II
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Intuitive Surgical
Warning
Class II
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Merit Medical Systems