Cook Incorporated
Bloomington, IN
This page shows every FDA and USDA recall linked to Cook Incorporated. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
64
Total Recalls
2022
First Recall
2025
Most Recent
Flexor Check-Flo Introducers and Sets, Reference Part Numbers:
1) KCFW-9.0-18/38-45-RB-ANL0-HC;
2) KCFW-9.0...
Dec 23, 2025
· Device
Active
Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100;
The Rsch-Uchida Transjugular L...
Dec 23, 2025
· Device
Active
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers:
1) RTPS-100;
2) RTPS-100-10.0;
The Rin...
Dec 23, 2025
· Device
Active
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Cat...
Jun 16, 2025
· Device
Active
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GP...
May 16, 2025
· Device
Active
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GP...
May 16, 2025
· Device
Active
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malforma...
May 14, 2025
· Device
Active
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Nov 21, 2024
· Device
Active
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW
Reference Part Numbers:
HMW-14-135-ST
HMW-14-190-ST
HM...
Nov 8, 2024
· Device
Active
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW;
Reference Part Numbers:
CMW-14-190-12G
CMW-14-...
Nov 8, 2024
· Device
Active
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percuta...
Jun 27, 2024
· Device
Active
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for pe...
Jun 27, 2024
· Device
Active
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devi...
Apr 12, 2024
· Device
Active
Chiba Biopsy Needle - Used for aspiration biopsy.
REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN):
1) DCHN-18...
Apr 12, 2024
· Device
Active
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the...
Apr 12, 2024
· Device
Active
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of dev...
Apr 12, 2024
· Device
Active
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for...
Apr 12, 2024
· Device
Active
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracen...
Apr 12, 2024
· Device
Active
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for p...
Apr 12, 2024
· Device
Active
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tape...
Apr 12, 2024
· Device
Active
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7....
May 10, 2023
· Device
Active
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLE...
May 10, 2023
· Device
Active
Roadrunner PC Wire Guide (The Firm), Guidewire
Reference Part Number/GPN
RPC-35-145 G06979
RPC-35-80 G09534
Sep 28, 2022
· Device
Active
Fixed Core Wire Guide, Guidewire
Reference Part Number/GPN
THSCF-25-180-3 G02165
TSCF-25-80-3 G00476
Sep 28, 2022
· Device
Active
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire;
Reference Part Numb...
Sep 28, 2022
· Device
Active
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire
Reference Part Number/GPN:
TSFNA-35-145 G00701...
Sep 28, 2022
· Device
Active
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire
Reference Part Number/GPN
PMG-18SP-60-COP...
Sep 28, 2022
· Device
Active
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire;
Reference Part Number/GPN:
PMG-18SP-60-COPE-NT-ST G09395...
Sep 28, 2022
· Device
Active
Fixed Core Wire Guide (Straight), Guidewire
Reference Part Number/GPN:
C-SF-18-30 G02261
C-SF-25-40 G01937
TSF...
Sep 28, 2022
· Device
Active
Roadrunner PC Wire Guide (Nimble), Guidewire
Reference Part Number/GPN:
RFSPC-35-145 G09607
Sep 28, 2022
· Device
Active
Double Flexible Tipped Wire Guide, Guidewire
Reference Part Number/GPN
TDOC-35-145-0-3 G00362
C-TDOC-18-50-0-2...
Sep 28, 2022
· Device
Active
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire
Reference Part Number/GPN:
RPC-035145-0-5 G34131
R...
Sep 28, 2022
· Device
Active
Coons Interventional Wire Guide, Guidewire;
Reference Part Number/GPN:
THSF-35-145-COONS G02356
THSF-38-145-CO...
Sep 28, 2022
· Device
Active
Bentson Wire Guide, Guidewire (OUS ONLY);
Reference Part Number:
TSMB-35-145 (GPN G27041)
Sep 28, 2022
· Device
Active
Vinyl Connecting Tube, Connecting Tube
Reference Part Number/GPN
CTU14.0-30-ST G02278
CTU14.0-40-ST G02327
CTU...
Sep 28, 2022
· Device
Active
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire
Reference Part Number/GPN
TCMTNA-35-145-3 G0167...
Sep 28, 2022
· Device
Active
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire;
Reference Part Number:
TSFB-35-80 (...
Sep 28, 2022
· Device
Active
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire
Reference Part Number/GPN:
TSCF-25-180-3 G01602
TSCF-35-180...
Sep 28, 2022
· Device
Active
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY)
Reference Part Number/GPN
TMT-35-145 G01677
Sep 28, 2022
· Device
Active
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire
RFPC-35-145 G07914
Sep 28, 2022
· Device
Active
Heavy Double Flexible Tipped Wire Guide, Guidewire
Reference Part Number/GPN:
THDOC-35-60-0-3 G11949
C-HDOC-18...
Sep 28, 2022
· Device
Active
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY);
Reference Part Number:
THSF-35-145-AES-SGH (GPN G0...
Sep 28, 2022
· Device
Active
Torq-Flex Wire Guide Australian Modification, Guidewire
Reference Part Number/GPN
STF-18-40-AUST G07304
Sep 28, 2022
· Device
Active
Rosen Curved Wire Guide, Guidewire
Reference Part Number/GPN
THSCF-35-220-1.5-ROSEN G01623
THSCF-35-80-1.5-ROS...
Sep 28, 2022
· Device
Active
Lunderquist -Ring Torque Wire Guide, Guidewire
Reference Part Number/GPN
THSF-35-125-THG G27031
THSF-35-145-TH...
Sep 28, 2022
· Device
Active
Roadrunner PC Wire Guide (The Firm LT), Guidewire
Reference Part Number/GPN
RLPC-35-145 G06866
Sep 28, 2022
· Device
Active
Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): RFSPC-35-180
ORDER NUMBER (GPN) G09608. F...
Jul 19, 2022
· Device
Active
Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWAS-35-150
ORDER NUMBER (GPN): G561...
Jul 19, 2022
· Device
Active
Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN)RFPC-35-180
ORDER NUMBER (GPN) G07937. For...
Jul 19, 2022
· Device
Active