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Cook Incorporated Recalls
85 recalls on record · June 15, 2022 to May 13, 2026 · Medical Devices
Recalls by year
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
November 20, 2024Medical DevicesFDA
Cook Incorporated recalls Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18
Hazard: Affected device lots have labels that state the incorrect expiration dates.
October 16, 2024Medical DevicesFDA
Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers ar
Hazard: 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.
July 3, 2024Medical DevicesFDA
Cook Incorporated recalls Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous
Hazard: Product labels state the incorrect expiration dates that extends beyond their true expiration date
July 3, 2024Medical DevicesFDA
Cook Incorporated recalls Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drai
Hazard: Product labels state the incorrect expiration dates that extends beyond their true expiration date
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneou
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for v
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or t
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
May 17, 2023Medical DevicesFDA
Cook Incorporated recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577
Hazard: 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 connection between the device connector and circuit components, cap, or accessories.
May 17, 2023Medical DevicesFDA
Cook Incorporated recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)
Hazard: 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 connection between the device connector and circuit components, cap, or accessories.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G2703
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-3
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-0351
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-26
Hazard: 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.
October 5, 2022Medical DevicesFDA
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 G009
Hazard: 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.
October 5, 2022Medical DevicesFDA
Cook Incorporated recalls Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Hazard: 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.