GE HEALTHCARE AUSTRIA GMBH &amp; CO Tiefenbach 15 Pfaffing Austria Recalls

The firm initiated a recall of SoyBean Sprouts because product tested positive for Listeria monocytogenes.

FDADec 20, 2023VA• Samsung Bean Sprout

iQ200 Urine Analyzers (Beckman Coulter) – Cannula Rust Risk (2023)

Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

REV 2 Flowcell (Beckman Coulter) – cannula rust problem (2023)

FDADec 19, 2023Nationwide• Boston Scientific Corporation

EndoVive Button Kit (Boston Scientific) – measurement error (2023)

Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.

iQ Waste Well Adapter (Beckman Coulter) – Cannula Rust Risk (2023)

DxU Microscopy Analyzers (Beckman Coulter) – Cannula Rust Risk (2023)

FDADec 18, 2023Nationwide• St. Jude Medical, Atrial Fibrillation Division, Inc.

TactiFlex Ablation Catheter (St. Jude) – System Recognition Issue (2023)

When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.

Publix Custom Burrito Bowls (Publix) – Listeria Contamination (2023)

The underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria monocytogenes.

FDADec 15, 2023AL, FL, GA +5 more• Publix Super Markets, Inc.

Publix Custom Made Platters (Publix) – Listeria Contamination (2023)

The underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria monocytogenes.

FDADec 15, 2023AL, FL, GA +5 more• Publix Super Markets, Inc.

Publix Custom Made Sub Sandwiches (Publix) – Listeria ingredient contamination (2023)

The underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria monocytogenes.

FDADec 15, 2023AL, FL, GA +5 more• Publix Super Markets, Inc.

Tacrolimus Capsules (Dr. Reddy's) – Foreign Tablet Discovered (2023)

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

Class IIModerate

FDADec 15, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

Publix Self Service Salad (Publix) – Listeria Contamination (2023)

The underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria monocytogenes.

FDADec 15, 2023AL, FL, GA +5 more• Publix Super Markets, Inc.

Publix Custom Made Pizzas (Publix) – Listeria ingredient contamination (2023)

The underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria monocytogenes.

FDADec 15, 2023AL, FL, GA +5 more• Publix Super Markets, Inc.

Chicken Street Tacos (Publix) – Potential Listeria (2023)

The underlying ingredient, shredded lettuce, was recalled by the supplier Fresh Express due to potential contamination with Listeria monocytogenes.