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All product recalls affecting Wisconsin.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Wisconsin in the distribution area.
CGMP Deviations: sterile water not used for production
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
Due to a manufacturing issue, red particulates present in the expressed composite.
TAXA LLC (TAXA) is recalling certain 2021-2024 Mantis trailers. The gaskets and brackets could fail to stabilize the freshwater tank, allowing the tank to move and detach from the trailer.
Doosan Bobcat North America, Inc. (Doosan) is recalling certain 2023 Bobcat PA185, and C185WD0-T4F portable compressor trailers. The wheel lug nuts may be improperly tightened.
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Due to a manufacturing issue, red particulates present in the expressed composite.
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
This recall involves the Origin 21 oval and rectangle wall mirrors. These mirrors were sold in black metal frames. The rectangle mirror measures 22 inches wide and 31 inches long, with model number L1-MH-1647. The oval mirror measures 24 inches wide and 36 inches long, with model number L1-MH-1693. The model numbers are printed on a label affixed to the back of the mirror.
This recall involves travel bassinets sold in dark gray, blue, light gray, pink, purple and sky blue. The bassinets fold open and closed, and have a mesh mosquito net that folds over the top. The model name "New Moon" is printed on the canopy, and the mattresses have a star pattern. The bassinets come with a bag with handles on the top. The brand "beberoad LOVE" is printed on the top of the bag. Only bassinets manufactured on or after June 23, 2022 are included in this recall. The model name, model number TB999-1, and manufacture date in DD/YYYY format are located on the bottom of the bassinet in a sewn-in tag.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.