Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) N...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or...
Z-1319-2026February 18, 2026Northfield, IL
Medline Industries, LP
Class IOngoing
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens ...
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or...
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or...
Reason: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may...
Z-1312-2026February 18, 2026Northfield, IL
Medline Industries, LP
Class IOngoing
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTA...
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or...
Reason: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may...
Z-1313-2026February 18, 2026Northfield, IL
Medline Industries, LP
Class IOngoing
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 40122...
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or...
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or...
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or...
Z-1323-2026February 18, 2026Northfield, IL
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted p...
Reason: Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; ...
Reason: Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to...
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0951-2026December 24, 2025Tyne & Wear
Rocket Medical Plc
Class IIOngoing
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a bar...
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0955-2026December 24, 2025Tyne & Wear
Draeger, Inc.
Class IOngoing
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a m...
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Z-0592-2026December 17, 2025Telford, PA
Draeger, Inc.
Class IOngoing
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a me...
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Z-0591-2026December 17, 2025Telford, PA
Draeger, Inc.
Class IOngoing
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mecha...
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Z-0590-2026December 17, 2025Telford, PA
Draeger, Inc.
Class IOngoing
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a m...
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Reason: Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in shar...
Z-0887-2026December 17, 2025Tempe, AZ
Sterilmed, Inc.
Class IIOngoing
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/...
Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such a...