Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
All Recalls
95,018 total recalls in our database
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
Advanced Accelerator Applications USA
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
ALEMBIC PHARMACEUTICALS
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
Covidien
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Centurion FMS Pak
Alcon Research
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Legion FMS Pak
Alcon Research
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Medtronic Neurosurgery
🏥 Medical Devices Class I - Dangerous
Product labeling contains incorrect expiration date
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
Covidien
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
Covidien
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
🏥 Medical Devices Class I - Dangerous
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Constellation Procedure Pak
Alcon Research
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.