Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W…
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Read the official notice →- Date
- 2025-10-22
- Country
- United States
- Brand
- Cook Medical
- Product
- Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W…
- Classification
- Class I
- Units
- Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medical recalls
- 2024-05-22
US
Cook Medical Incorporated recalls EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Devices may contain elevated levels of bacterial endotoxin.
FDA · DeviceCook Medical IncorporatedInternational distribution in the countries of Germany, Netherlands,…Official notice →- 2024-01-24
US
Cook Medical Llc recalls MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional…
FDA · DeviceCook Medical LlcDomestic distribution to CA IN LA MD NY International distribution to…Official notice →- 2022-04-13
US
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP…
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
FDA · DeviceCook Medical IncorporatedUS Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile GuamOfficial notice →
Other drugs & medical recalls in the United States
- 2025-10-22
US
MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536,…
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may…
FDA · DeviceMICROVENTION INC.Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL,…Official notice →US
Boston Scientific Corporation recalls Model Number L211 PROPONENT DR SL MRI Pacemaker
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes…
US
Olympus Corporation of the Americas recalls EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
US
Percussionaire Corporation recalls Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line…
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of…
FDA · DevicePercussionaire CorporationWorldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada,…Official notice →US
Rising Pharma Holding, Inc. recalls Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings,…
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and…
US