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Showing 5421–5440 of 68218 results

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Supreme Peppers (Yummi Sushi) – Listeria risk (2024)

possible contamination with Listeria Monocytogenes.

FDAJul 19, 2024IN• GBC Food Services, LLC dba Yummi Sushi

BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure f... (Becton Dickinson & Co.) – may intermittently produce falsely re... (2024)

May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

FDAJul 18, 2024Nationwide• Becton Dickinson & Co.

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.

High

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.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

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.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

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.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

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.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

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

Class IIModerate

FDAJul 18, 2024Nationwide• FDC Limited

Acetaminophen (Granules) – Label Mix-up (2024)

Label mix-up: Carton incorrectly labeled.

FDAJul 18, 2024IL, IN• Granules Consumer Health Inc.

Umary Acido Hialuronico (MAIN PRODUCTS) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

FDAJul 18, 2024Nationwide• MAIN PRODUCTS INC

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.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

Mazor X. Model Number REF TPL0059; stereotaxic orthopedic... – software anomalies which can result i... (2024)

Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.

FDAJul 17, 2024Nationwide

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)

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

St. Jerome Cheese (Kenny's Farmhouse) – Listeria risk (2024)

Potential contamination with Listeria monocytogenes

FDAJul 17, 2024AL, GA, ID +4 more• Kenny's Farmhouse Cheese

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