💊 Drugs Class I - Dangerous
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
All Recalls
95,102 total recalls in our database
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
💊 Drugs Class I - Dangerous
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
💊 Drugs Class I - Dangerous
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
💊 Drugs Class I - Dangerous
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
💊 Drugs Class I - Dangerous
Failed Dissolution Specification
🏥 Medical Devices Class I - Dangerous
The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
Implant Direct Sybron Manufacturing
🏥 Medical Devices Class I - Dangerous
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Thin-Flex Venous Cannula, Model Number:TF292902A
Edwards Lifesciences
🏥 Medical Devices Class I - Dangerous
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
🏥 Medical Devices Class I - Dangerous
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
🏥 Medical Devices Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
🏥 Medical Devices Class I - Dangerous
The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.
🏥 Medical Devices Class I - Dangerous
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
🏥 Medical Devices Class I - Dangerous
Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
🏥 Medical Devices Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
🏥 Medical Devices Class I - Dangerous
A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
🏥 Medical Devices Class I - Dangerous
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
🏥 Medical Devices Class I - Dangerous
Complaints that the ratchet teeth of the tube are not latching onto the rod.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
🏥 Medical Devices Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification