🏥 Medical Devices • 6,839 recalls
Boston Scientific
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
Unapproved change made by the supplier.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Arrow International
Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.