Cook Incorporated
Complete recall history across all FDA and CPSC categories — 64 total recalls
Cook Incorporated appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (64)
FDA medical device enforcement actions by Cook Incorporated. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 2, 2026 | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G... | Marker bands may be at an increased risk of cracking/breakage. Potential adve... | Class I |
| Apr 2, 2026 | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G... | Marker bands may be at an increased risk of cracking/breakage. Potential adve... | Class I |
| Apr 2, 2026 | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 C... | Marker bands may be at an increased risk of cracking/breakage. Potential adve... | Class I |
| Mar 5, 2026 | COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Nu... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAY... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Re... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: R... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200,... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-19... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-1... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: ... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part N... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Par... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Mar 5, 2026 | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.... | Products from the affected device lots were labeled with expiration dates tha... | Class II |
| Nov 26, 2025 | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTP... | Cook Medical identified that products supplied in the affected device lots ma... | Class II |
| Nov 26, 2025 | R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-10... | Cook Medical identified that products supplied in the affected device lots ma... | Class II |
| Nov 26, 2025 | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0... | Cook Medical identified that products supplied in the affected device lots ma... | Class II |
| May 15, 2025 | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... | Cook Medical identified that catheters supplied in the affected device lots m... | Class I |
| Apr 17, 2025 | Tornado Embolization Microcoil, intended for embolization of selective vessel... | Cook Medical identified that devices from the affected device lots may contai... | Class II |
| Apr 17, 2025 | Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-... | Cook Medical identified that devices from the affected device lots may contai... | Class II |
| Apr 17, 2025 | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-... | Cook Medical identified that devices from the affected device lots may contai... | Class II |
| Oct 14, 2024 | Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 | Devices from the affected device lots have labels that state the incorrect ex... | Class II |
| Oct 8, 2024 | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference P... | Affected device lots have labels that state the incorrect expiration dates. | Class II |
| Oct 8, 2024 | Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numb... | Affected device lots have labels that state the incorrect expiration dates. | Class II |
| Sep 16, 2024 | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Or... | Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer... | Class II |
| May 15, 2024 | Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0... | Product labels state the incorrect expiration dates that extends beyond thei... | Class II |
| May 15, 2024 | Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-... | Product labels state the incorrect expiration dates that extends beyond thei... | Class II |
| Mar 1, 2024 | Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Mar 1, 2024 | Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Mar 1, 2024 | Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts f... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Mar 1, 2024 | Trocar Needle - Used for dilating puncture sites or catheter tracts for percu... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Mar 1, 2024 | Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous f... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Mar 1, 2024 | Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Mar 1, 2024 | Dilator - Intended to be used for dilating puncture sites or catheter tracts ... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Mar 1, 2024 | Peel-Away Introducer - Intended for the percutaneous introduction of balloon,... | Packaging may have low seal strength and not meet peel strength specification... | Class II |
| Apr 7, 2023 | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ... | There were reports from customers that the tracheostomy in the sets and trays... | Class I |
| Apr 7, 2023 | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part... | There were reports from customers that the tracheostomy in the sets and trays... | Class I |
| Aug 16, 2022 | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/... | Cook Medical identified that devices from the affected device lots may have a... | Class II |
| Aug 16, 2022 | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFS... | Cook Medical identified that devices from the affected device lots may have a... | Class II |
| Aug 16, 2022 | Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF... | Cook Medical identified that devices from the affected device lots may have a... | Class II |
| Aug 16, 2022 | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 | Cook Medical identified that devices from the affected device lots may have a... | Class II |
| Aug 16, 2022 | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Par... | Cook Medical identified that devices from the affected device lots may have a... | Class II |
| Aug 16, 2022 | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF... | Cook Medical identified that devices from the affected device lots may have a... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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