Recall archive
17 recalls · page 1 of 1
Reported Oct 21, 2026Updated Oct 26, 2026
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing…
FDA (openFDA device enforcement)
Reported May 13, 2026
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
Matched: Brand — Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 15, 2026
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand · Product · Product details — Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand · Reason for recall — Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
Matched: Brand · Reason for recall — Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
FDA (openFDA device enforcement)
Reported May 28, 2025
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand · Reason for recall — Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 21, 2025
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand · Reason for recall — Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — Devices from the affected device lots have labels that state the incorrect expiration dates.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — Affected device lots have labels that state the incorrect expiration dates.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — Product labels state the incorrect expiration dates that extends beyond their true expiration date
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 17, 2023
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
Matched: Brand — There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand · Reason for recall — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the…
23 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if…
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
Matched: Brand — The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
2 more products in this recall
FDA (openFDA device enforcement)
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