Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.

High

FDAJul 19, 2024Nationwide• Inari Medical Oak Canyon

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.

Low

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

Butternut Squash Cubes (JFE Franchising) – Listeria risk (2024)

Listeria

Listeria monocytogenes

Class IHigh

FDAJul 19, 2024KY, MI, OH +1 more• JFE FRANCHISING INC

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.

High

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.

Low

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.

Moderate

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.

Moderate

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.

Low

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.

Moderate

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.

Moderate

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.

Moderate

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.

Moderate

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.

High

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

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.

Class IHigh

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.

High

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.

Moderate

FDAJul 17, 2024Nationwide

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