Cook recalls
20 official recalls and safety alerts involving Cook since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Cook or the relevant agency.
- 2026-05-13
USCook 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…
FDA · DeviceCook IncorporatedUS distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China,…Official notice →- 2026-04-15
- US
Cook 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
- US
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
- US
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
- US
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
- US
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
- US
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.
- 2024-11-20
- US
Cook Incorporated recalls Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Affected device lots have labels that state the incorrect expiration dates.
- 2024-10-16
- US
Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to…
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 hub of these products may disconnect.
FDA · DeviceCook IncorporatedInternational distribution to the country of Australia.Official notice → - 2024-07-03
- US
Cook Incorporated recalls Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety…
Product labels state the incorrect expiration dates that extends beyond their true expiration date
- 2024-04-24
- US
Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into…
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
FDA · DeviceCook IncorporatedWorldwide distribution - US Nationwide and the countries of AT, AU, BR, CA,…Official notice → - 2023-05-17
- US
Cook Incorporated recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725),…
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 circuit components and accessories. This resulted in an unsecure…
- 2022-10-05
- US
Cook Incorporated recalls Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
FDA · DeviceCook IncorporatedDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2022-09-21
- US
Cook Incorporated recalls Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter…
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
FDA · DeviceCook IncorporatedNationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU…Official notice → - 2022-07-20
- US
Cook Incorporated recalls Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a…
- 2022-06-15
- US
Cook Incorporated recalls Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338…
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
FDA · DeviceCook IncorporatedDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2021-12-29
- US
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - 2021-12-22
- US
Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce…
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
FDA · DeviceCook Inc.AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES,…Official notice → - 2021-11-24
- US
Cook Inc. recalls Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal…
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time…
FDA · DeviceCook Inc.Domestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2021-11-10
- US
Cook Inc. recalls Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath…
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in…
FDA · DeviceCook Inc.Domestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA.…Official notice →