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Showing 1361–1380 of 3001 results

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LIFEPAK 15 (Physio-Control) – Inspection Failure (2025)

Due to required inspections not being performed on products/units that have gone through servicing.

FDAJul 22, 2025Nationwide• Physio-Control, Inc.

LIFEPAK CR2 (Physio-Control) – Inspection Failure (2025)

Due to required inspections not being performed on products/units that have gone through servicing.

FDAJul 22, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 1000 (Physio-Control) – Inspection Failure (2025)

Due to required inspections not being performed on products/units that have gone through servicing.

Moderate

FDAJul 22, 2025Nationwide• Physio-Control, Inc.

Strawberry Bread (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

Cheese Bread (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

RefleXion X1 (Reflexion Medical) – Software Configuration Risk (2025)

Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

FDAJul 22, 2025Nationwide• Reflexion Medical, Inc.

Cinnamon Pecan Fritters (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

Bartels ELISA Legionella Test (Trinity Biotech) – Particulate Matter (2025)

Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

FDAJul 22, 2025Nationwide• Trinity Biotech USA

BZK Antiseptic Towelette (Taizhou Kangping) – Sterility Issue (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAJul 22, 2025NY• Taizhou Kangping Medical Science And Technology Co., Ltd.

Fresh Apple Bread (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

Passionflower Herb Extract (Martin Bauer) – Misbranding (2025)

Misbranding of the ingredient the firm sells ( Passionflower Herb Extract )

Class IIModerate

FDAJul 22, 2025IN, NC• Martin Bauer, Inc.

Fresh Peach Bread (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

Strawberry Fritter (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

Apple Fritter (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

Jalapeno Cheese Bread (Hillside Orchard) – Undeclared Egg (2025)

Undeclared egg.

FDAJul 22, 2025AL, GA, NC +2 more• Hillside Orchard Farms Inc.

Amlodipine Olmesartan Tablets (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications: low dissolution results

Class IIModerate

FDAJul 21, 2025Nationwide• Ascend Laboratories, LLC

t:slim X2 G5 Insulin Pump (Tandem) – Alert Malfunction (2025)

Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.

FDAJul 21, 2025Nationwide• Tandem Diabetes Care, Inc.

STA-Fibrinogen 5 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 8 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 4 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

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