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.
Read the official notice →- Date
- 2024-11-27
- Country
- United States
- Brand
- Cook
- Product
- Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
- Classification
- Class II
- Units
- International Distribution to: Korea only
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-06-25
USCook 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.
- 2025-05-28
- US
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.
FDA · DeviceCook IncorporatedWorldwide distribution - US Nationwide and the countries of Belgium, Germany,…Official notice → - 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.
- 2024-11-20
- 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.
- 2024-10-16
- US
Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to…
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
FDA · DeviceCook IncorporatedInternational distribution to the country of Australia.Official notice → - 2024-07-03
- US
Cook Incorporated recalls Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety…
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Other drugs & medical recalls in the United States
- 2024-11-27
- US
Zyno Medical LLC recalls Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous…
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- US
OrganOx Ltd recalls OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx…
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
FDA · DeviceOrganOx LtdCalifornia, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma,…Official notice → - US
NuVasive Specialized Orthopedics, Inc. recalls Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX…
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
FDA · DeviceNuVasive Specialized Orthopedics, Inc.U.S distribution to states of: FL and NV.Official notice → - US
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number:…
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors…
FDA · DeviceOlympus Corporation of the AmericasDomestic: US Nationwide Distribution.Official notice → - US
Philips Medical Systems Technologies Ltd. recalls Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to…
A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in…
FDA · DevicePhilips Medical Systems Technologies Ltd.US Nationwide and Worldwide Distribution Foreign: Country Argentina Australia…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and…
A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina…Official notice →