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Panaderia Guatemex

Panaderia Guatemex Recalls

All product recalls associated with Panaderia Guatemex.

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Recall Summary

Total Recalls

1000

Past Year

123

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 201–220 of 2383 recalls

Champurradas (Panaderia Guatemex) – Undeclared Soy (2024)

Undeclared Allergen

Undeclared Allergen - Soy

Class IIModerate

FDAJul 2, 2024GA, KY, TN• Panaderia Guatemex

Pegado (Panaderia Guatemex) – Undeclared Soy (2024)

Undeclared Allergen

Undeclared Allergen - Soy

Class IIModerate

FDAJul 2, 2024GA, KY, TN• Panaderia Guatemex

Gore Viabahn VBX Heparin (Gore) – Packaging Defects (2024)

Due to packaging defects, sterility assurance and heparin activity may be compromised.

High

1...9 101112 13...120

Page 11 of 120Next

FDA

Jul 1, 2024

Nationwide

• W L Gore & Associates, Inc.

HeartMate 3 System Controller (Thoratec) – UI Membrane Risk (2024)

Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

High

FDAJun 25, 2024AL, AZ, AR +39 more• Thoratec LLC

Dandelion Chocolate Cocoa Nibs – Hazelnut Allergen (2024)

Undeclared Allergen

Undeclared allergen - hazelnuts

Class IIModerate

FDAJun 20, 2024CA, NV• Dandelion Chocolate

SURGICEL Fibrillar (Ethicon) - Packaging Integrity (2024)

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

Moderate

FDAJun 11, 2024Nationwide• Ethicon Sarl, a Johnson & Johnson Company rue du Puits-Godet 20 Neuchatel Switzerland

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

High

FDAMay 22, 2024Nationwide• Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

Ultrathane Cook-Cope Drainage Catheter (Cook) – Incorrect Expiration (2024)

Product labels state the incorrect expiration dates that extends beyond their true expiration date

Low

FDAMay 15, 2024MA• Cook Incorporated

Ultrathane Mac-Loc Drainage Catheter (Cook) – Incorrect Expiration (2024)

Product labels state the incorrect expiration dates that extends beyond their true expiration date

Low

FDAMay 15, 2024MA• Cook Incorporated

Duloxetine Capsules (Golden State) – Nitrosamine Contamination (2024)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Golden State Medical Supply Inc.

HeartMate System Monitor (Thoratec) – Screen Display Problem (2024)

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

High

FDAMay 8, 2024Nationwide• Thoratec Corp.