Cook Incorporated recalls Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Read the official notice →- Date
- 2025-05-28
- Country
- United States
- Brand
- Cook
- Product
- Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Belgium, Germany,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Cook recalls
- 2026-04-15
USCook Incorporated recalls COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2025-12-31
- US
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3)…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not…
- 2025-06-25
- US
Cook Incorporated recalls Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in…
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
- 2025-05-21
- US
Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular…
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
- 2024-11-27
- US
Cook Incorporated recalls Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Devices from the affected device lots have labels that state the incorrect expiration dates.
- 2024-11-20
- US
Cook Incorporated recalls Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Affected device lots have labels that state the incorrect expiration dates.
Other drugs & medical recalls in the United States
- 2025-05-28
- US
Echopixel, Inc. recalls TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care…
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
FDA · DeviceEchopixel, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA,…Official notice → - US
Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw,…
FDA · DeviceSmith & Nephew, Inc.Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH,…Official notice → - US
Philips North America Llc recalls Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Andorra,…Official notice → - US
Echopixel, Inc. recalls True 3D Viewer, Model: EP-00003
With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from…
FDA · DeviceEchopixel, Inc.Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
- US
Centerline Biomedical Inc recalls Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a…
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
FDA · DeviceCenterline Biomedical IncUS distribution to states of: Pennsylvania, Florida, Texas, New York, North…Official notice →