Cook Incorporated recalls Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a…
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a…
Read the official notice →- Date
- 2026-05-13
- Country
- United States
- Brand
- Cook
- Product
- Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a…
- Classification
- Class I
- Units
- US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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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
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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
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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.
- 2025-05-28
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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
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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
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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.
Other drugs & medical recalls in the United States
- 2026-05-13
- US
American Contract Systems Inc recalls Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers…
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential…
FDA · DeviceAmerican Contract Systems IncUS distribution to MN. No OUS distribution.Official notice → - US
AVID Medical, Inc. recalls Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
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Ventec Life Systems, Inc. recalls VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could…
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Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
FDA · DeviceIntuitive Surgical, Inc.US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice → - US
- US
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles recalls TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single…
Incorrect Product Formulation: product did not contain insulin as listed in the label.