Stryker Neurovascular recalls The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The…
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer…
Read the official notice →- Date
- 2024-06-12
- Country
- United States
- Brand
- Stryker Neurovascular
- Product
- The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of TX, NY, MD,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Stryker Neurovascular recalls
- 2026-07-01
USStryker Neurovascular recalls INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended,…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of PA, AZ, FL,…Official notice →- 2024-10-16
- US
Stryker Neurovascular recalls The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end…
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed…
FDA · DeviceStryker NeurovascularU.S. Nationwide distribution in the states of CA and VA.Official notice → - 2024-06-05
- US
Stryker Neurovascular recalls Trevo ProVue, Catalog: 90184
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of MN, PA, IL,…Official notice → - 2024-05-08
- US
Stryker Neurovascular recalls The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a…
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification…
FDA · DeviceStryker NeurovascularUS Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA,…Official notice → - 2022-07-27
- US
Stryker Neurovascular recalls Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;…
Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
FDA · DeviceStryker NeurovascularWorldwide distribution - US Nationwide distribution in the states of CA, OR,…Official notice →
Other drugs & medical recalls in the United States
- 2024-06-12
- US
BD SWITZERLAND SARL recalls Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of…
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
FDA · DeviceBD SWITZERLAND SARLWorldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS,…Official notice → - US
Securitas Healthcare LLC recalls Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the…
The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience…
FDA · DeviceSecuritas Healthcare LLCWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
WAVi Co. recalls WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart…
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
FDA · DeviceWAVi Co.US: NC, TX, IL, NV, AZ, NY, CA, MI, KS, AL, FL, MD, UT, WA, PA, GA, AR, NM,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Panama,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR,…
These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Panama.Official notice → - US
CORENTEC CO., LTD recalls LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Due to unsupported 10 year expiration date.
FDA · DeviceCORENTEC CO., LTDUS Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.Official notice →