Cook Incorporated recalls
Every recall we track for Cook Incorporated — 86 in all, from 2022–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Cook Incorporated halved in 2025 (7, down from 14 in 2024). 5% rated “stop using now”.
All FDA recall records for Cook Incorporated since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 2 | 2 | 35 | 2 | 41 |
| 2023 | 0 | 2 | 0 | 0 | 2 |
| 2024 | 0 | 0 | 14 | 0 | 14 |
| 2025 | 0 | 1 | 6 | 0 | 7 |
| 2026 (to date) | 2 | 1 | 19 | 0 | 22 |
Most common reasons for Cook Incorporated recalls
What to do if you have a recalled Cook Incorporated product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Cook Incorporated recalls
17 shown- Lower riskMedical device
Cook Incorporated recalls Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder
Cook Incorporated recalls 97 cystoscopic injection needles (Lot 16613606, 16951548, 16951548X) due to potential misalignment causing inadequate treatment. Affected units sold in US states FL, IL, NM, TX, WA and Canada, France, Germany, Italy, Spain, Switzerland.
Cook IncorporatedSep 16, 2026 - Stop using nowMedical device
Cook Incorporated recalls Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are
Cook recalls certain Centimeter Sizing Catheters for angiographic procedures due to marker bands that may crack, causing device fragmentation and vessel injury. Affected units include specific model numbers and lots.
CookApr 2, 2026 - Lower riskMedical device
Cook Incorporated recalls COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412;
Cook Medical recalls arterial pressure monitoring trays with expiration dates exceeding true shelf life. Affected units may degrade over time, but no injuries reported. Consumers should check model numbers and lot codes.
Cook MedicalMar 5, 2026 - Lower riskMedical device
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2)
Cook recalls Flexor Check-Flo Introducers and Sets with specific part numbers due to potential manufacturing defects that may cause improper length, trimming, or inspection.
CookNov 26, 2025 - Use cautionMedical device
Cook Incorporated recalls Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters
Cook recalls Beacon Tip 5.0 Fr Angiographic catheters with specific lot numbers due to potential tip separation. Affected units may require replacement to prevent complications during medical procedures.
CookMay 15, 2025 - Lower riskMedical device
Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and
Cook recalls Tornado Embolization Microcoils with incorrectly sized coils that could lead to improper treatment. Affected lots include specific model numbers and serials. Consumers should contact Cook for details.
CookApr 17, 2025 - Lower riskMedical device
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
Cook recalls Check=Flo Performer Introducer devices with incorrectly sized introducer sheaths. Affected units may cause complications during medical procedures. Contact Cook for details.
CookApr 17, 2025 - Lower riskMedical device
Cook Incorporated recalls Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Cook recalls Approach CTO Micro Wire Guide with incorrect expiration dates on labels. Affected lots may have safety risks if used beyond expiration.
CookOct 14, 2024 - Lower riskMedical device
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
Cook recalls Approach Hydro ST Micro Wire Guides with incorrect expiration dates on labels. Affected units include specific catalog prefixes and part numbers. Consumers should check labels for correct expiration dates.
CookOct 8, 2024 - Lower riskMedical device
Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers
Cook recalls Check-Flo Performer Introducer Sets with reference part number RCF-5.0-35-45-J due to white caps potentially disconnecting, which could cause medical complications during use.
CookSep 16, 2024 - Lower riskMedical device
Cook Incorporated recalls Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous
Cook recalls Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheters with incorrect expiration dates that extend beyond their true expiration. Affected units may cause safety risks if used after the actual expiration date.
CookMay 15, 2024 - Lower riskMedical device
Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end
Cook recalls Peel-Away Introdu: Packaging may have low seal strength, risking device sterility. Affected units sold with specific part numbers. Stop using immediately if you own the recalled model.
CookMar 1, 2024 - Use cautionMedical device
Cook Incorporated recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5
Cook recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays with reference part numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 and others due to unsecure connections that could lead to disconnection during use.
CookApr 7, 2023 - Lower riskMedical device
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
Cook recalls specific Fixed Core Wire Guide (Safe-T-J Curved) models due to potential packaging sterility breach. Affected items may not be sterile, risking infection during medical procedures. Check part numbers and expiration dates listed.
CookAug 16, 2022 - Lower riskMedical device
Cook Incorporated recalls Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For
Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWAS-35-150) due to potential sterility compromise from inadequate packaging testing. Affected units include specific lot numbers for vascular catheter procedures.
CookJul 19, 2022 - Use cautionMedical device
Cook Incorporated recalls Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Cook recalls pressure monitoring sets with excess coating that could cause blood clots or delayed procedures. Affected units have specific lot numbers and model codes.
CookMay 25, 2022 - Lower riskMedical device
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
Cook has recalled certain Nester Embolization Microcoil models due to a small stainless steel piece that could detach and cause injury.
CookMay 5, 2022
Cook Incorporated recall questions
How many recalls has Cook Incorporated had?
86 recalls from Cook Incorporated are on record with U.S. safety agencies, from 2022–2026.
What is the most recent Cook Incorporated recall?
Cook Incorporated recalls Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder, dated Sep 16, 2026. Every Cook Incorporated recall is listed on this page, newest first.
Why are Cook Incorporated products recalled?
The most common reasons on record: Affected device lots have labels that state the incorrect expiration dates. (2).
What should I do if I have a recalled Cook Incorporated product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Cook Incorporated recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.