Cuban Crackers Galletas Cubanas, Net Wt 8Oz (226g). Distributed by Best Floridian, LLC. UPC 5700300060
Lily's Bakery Factory
🍎 Food Class I - Dangerous
Undeclared colors FD&C yellow #5, FD&C yellow #6, and FD&C red 40
All Recalls
95,102 total recalls in our database
🍎 Food Class I - Dangerous
Undeclared colors FD&C Yellow #5
Undeclared allergen (fish). Anthony's Barbecue & Dip-It Sauce label does not declare Worcestershire (Anchovy).
🍎 Food Class I - Dangerous
Undeclared colors FD&C Yellow #5
🍎 Food Class I - Dangerous
Undeclared Milk. Wrong product in container.
🍎 Food Class I - Dangerous
Undeclared colors FD&C Yellow #5
💊 Drugs Class I - Dangerous
Failed PH Specifications
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Zydus Pharmaceuticals (USA)
💊 Drugs Class I - Dangerous
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.
Graviti Pharmaceuticals Private Limited
💊 Drugs Class I - Dangerous
Presence of Foreign Substance
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
Specialty Process Labs
💊 Drugs Class I - Dangerous
Subpotent Drug
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
🏥 Medical Devices Class I - Dangerous
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
🏥 Medical Devices Class I - Dangerous
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Philips Azurion system; Software Version Number: R3.1;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
🏥 Medical Devices Class I - Dangerous
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Allwell Inflation Device, for angiographic use REF: IS-30-A
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
Inflation device handle may detach from the syringe during procedure.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
🏥 Medical Devices Class I - Dangerous
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.