Manufacturer

Cook Incorporated

85 recalls in our database name Cook Incorporated as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–85 of 85

HighFDA (Devices)·Z-1709-2022·2022-09-21
Roadrunner PC Wire Guide Recalled for Sterility Testing Failure
Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1712-2022·2022-09-21
Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall
Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2022·2022-09-21
Vascular wire guides recalled due to potential sterility compromise
Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1717-2022·2022-09-21
Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise
Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure
Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1714-2022·2022-09-21
Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1362-2022·2022-07-20
Pressure Monitoring Sets with Excess Coating Pose Embolism Risk
Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.
Product
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1240-2022·2022-06-15
Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula
Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.
Product
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1241-2022·2022-06-15
Cook Nester Embolization Microcoil recalled for unintended cannula defect
Cook Incorporated recalls Nester Embolization Microcoil devices whose loading cartridges may contain an unintended stainless-steel cannula. Affected devices were distributed domestically and worldwide.
Product
Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1242-2022·2022-06-15
Tornado Embolization Microcoils recalled for unintended cannula in loading cartridges
Cook Incorporated is recalling certain Tornado Embolization Microcoils due to unintended stainless-steel cannulas in loading cartridges. The foreign objects may affect device function.
Product
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-1
Category
Medical Device
Distribution
Distributed nationwide