Cordis US Corp recalls Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
product mix-up; Vascular stent labeled as one size but contains a different size.
Read the official notice →- Date
- 2025-04-09
- Country
- United States
- Brand
- Cordis
- Product
- Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
- Classification
- Class II
- Units
- US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Cordis recalls
- 2025-03-19
USCordis US Corp recalls Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular…
Catheter manufactured at the incorrect length.
- 2024-01-17
- US
Cordis US Corp recalls MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903…
- 2023-11-15
- US
Cordis US Corp recalls Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Non-sterile product labeled as sterile was distributed.
- 2023-05-17
- US
Cordis US Corp recalls ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical…
- 2022-12-21
- US
Cordis US Corp recalls Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
There is a potential for separation at the male connector.
FDA · DeviceCordis US CorpNationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV,…Official notice → - 2022-07-20
- US
Cordis US Corp recalls PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
FDA · DeviceCordis US CorpUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →
Other drugs & medical recalls in the United States
- 2025-04-10
- US
Kramer Laboratories Recalls Safetussin Max Strength Multi-Symptom Cough, Cold and Flu Blister Packs Due to Risk of Child Poisoning; Violation of Federal Regulation for…
The Safetussin over-the-counter cold medicine contains acetaminophen, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the products is not child-resistant…
- 2025-04-09
- US
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC…
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the…
FDA · DeviceBeckman Coulter Inc.Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID,…Official notice → - US
Ethicon Endo Surgery, LLC recalls PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Identified curing issues with the silicone during the needles manufacturing process.
FDA · DeviceEthicon Endo Surgery, LLCWorldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of:…Official notice → - US
BD SWITZERLAND SARL recalls BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are…
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
FDA · DeviceBD SWITZERLAND SARLU.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO,…Official notice → - US
PYRAMES INC recalls Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator…
- US
Medtronic Neuromodulation recalls A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →