Izzio Artisan Bakery, LLC Recalls

FDAJul 20, 2024AZ, FL, IL +5 more• Izzio Artisan Bakery, LLC

Aldi Mixed Sourdough Loaf (Izzio) – Foreign Material Risk (2024)

Potential foreign material - plastic

FDAJul 20, 2024AZ, FL, IL +5 more• Izzio Artisan Bakery, LLC

Everything Sourdough (Izzio) – Foreign Material Risk (2024)

Potential foreign material - plastic

FDA

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Jul 20, 2024

AZ, FL, IL +5 more

• Izzio Artisan Bakery, LLC

2024 DOOSAN PORTABLE POWER MOBILE GENERATOR – doosan north america, inc (2024)

Doosan North America, Inc. (Doosan) is recalling certain 2024 Bobcat PG25 portable generator trailers. The wheel lug nuts may be improperly tightened.

NHTSAJul 19, 2024Nationwide• DOOSAN PORTABLE POWER

BioButton REF BIOST06040 with Software version 3.0.20 Th... (Biointellisense Inc. 570 El Camino Real) – software anomaly causing the skin tem... (2024)

Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.

FDAJul 19, 2024CA, CO, MA +2 more• Biointellisense Inc. 570 El Camino Real

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Cathe... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

smiths medical portex, Y' PIECE 15MM, REF 100/276/000 (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

smiths medical portex, Nasopharyngeal Airway, Sizes as fo... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

Flexima Regular Kit Nephrostomy Catheter System Kit, Mate... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

prodisc C SK, Total cervical disc replacement, medical d... (Centinel Spine, Inc.) – during the assembly of prodisc c, a b... (2024)

During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.

FDAJul 18, 2024Nationwide• Centinel Spine, Inc.

smiths medical portex, 15mm Double Swivel Connector: a... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

smiths medical portex, Thermovent 1200, 15mm/22mm: a) RE... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

Flexima APDL Drainage Catheter System and Kit, Material N... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

Flexima Regular Kit Biliary Catheter System Kit, Material... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

VTC Regular Kit Nephrostomy Catheter System Kit, Material... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

Timolol Maleate Solution (FDC) – Defective Container (2024)

Defective container; yellow colored spike from cap lodged in the nozzle

FDAJul 18, 2024Nationwide• FDC Limited

smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHE... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

PE Centrifuge, REF: B36365, a component of the Power Express (Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany) – metal contamination (2024)

The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

FDAJul 17, 2024Nationwide• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

Power Express, REF B90918 (Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany) – metal contamination (2024)

FDAJul 17, 2024Nationwide• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

PE Centrifuge Temperature Controlled, REF: B36366, a comp... (Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany) – metal contamination (2024)