Cook Inc. recalls
Every recall we track for Cook Inc. — 206 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them. 29 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Cook Inc. peaked in 2019 (111); 206 since 2017. 14% rated “stop using now”.
All FDA recall records for Cook Inc. 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 | 6 | 24 | 2 | 32 |
| 2018 | 1 | 8 | 13 | 0 | 22 |
| 2019 | 7 | 23 | 78 | 3 | 111 |
| 2020 | 21 | 4 | 8 | 0 | 33 |
| 2021 | 0 | 2 | 6 | 0 | 8 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Cook Inc. recalls
What to do if you have a recalled Cook Inc. 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 Inc. recalls
39 shown- Lower riskMedical device
Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155
Cook recalls Flexor Check-Flo Introducer Ansel Modification Model KCFW-7.0-18/38-45-RB-ANL0-HC due to mislabeling that may mix 6FR and 7FR devices.
CookNov 12, 2021 - Lower riskMedical device
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide
Cook recalls Skinny Needle with Chiba Tip (RPN 090010, GPN G14254) due to potential black debris causing local inflammatory reactions. Affected units may need replacement.
CookOct 13, 2021 - Use cautionMedical device
Cook Inc. recalls Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter,
Cook recalls Transseptal Needle with Catheter (RPN TSN-17-75.0-ENDRYS) due to potential rust on the needle that could cause inflammatory reactions or serious injury.
CookOct 8, 2021 - Lower riskMedical device
Cook Inc. recalls Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The
Cook recalls Flexor Check-Flo Introducer with incorrect radiopaque marker band placement, potentially causing longer procedures during medical imaging. Affected lots may need replacement.
CookSep 28, 2021 - Use cautionMedical device
Cook Inc. recalls Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal
Cook Medical recalls ureteral stent sets with incorrect material that may break during use. Affected models include 7.0Fr. 22-32cm for ESWL procedures. Contact for return or replacement.
CookJan 4, 2021 - Stop using nowMedical device
Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening events like hemorrhage or vessel injury.
CookNov 24, 2020 - Lower riskMedical device
Cook Inc. recalls Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured
Cook recalls Fixed Core Wire Guide RPN TSCF-35-260-3 with possible bent wire or loose foreign matter from manufacturing defects.
CookOct 22, 2020 - Lower riskMedical device
Cook Inc. recalls Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The
Cook recalls pediatric nephrostomy stent sets with reference part numbers 080208-S6/S7 and order numbers G15034/G15035 due to reduced indwell time from 4 months to 4 weeks. The current instructions for use are being updated.
CookAug 31, 2020 - Use cautionMedical device
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Grafts with excess glue in the handle that may prevent proper deployment. Affected units have specific reference part numbers and lot numbers listed in the recall notice.
Cook Inc.Aug 11, 2020 - Lower riskMedical device
Cook Inc. recalls Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for
Cook recalls Universa Soft Ureteral Stent Sets (UFH-526) due to incorrect outer box labeling that may confuse with Firm Stent Sets. This could lead to improper use.
CookJul 30, 2020 - Use cautionMedical device
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular
Cook recalls Zenith Alpha Abdominal Endovascular Grafts with catalog prefix ZIMB due to potential damaged bushing that could prevent proper deployment. Affected units may need replacement.
CookJun 2, 2020 - Lower riskMedical device
Cook Inc. recalls Pressure Monitoring Set, C-PMS, G02838
Cook recalls Pressure Monitoring Set C-PMS G02838 with lot numbers 8910219-10148417 due to potential excess coating on needles that could cause blockage during use.
CookApr 30, 2020 - Use cautionMedical device
Cook Inc. recalls Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent
Cook Inc. recalls Formula 418 Renal Balloon-Expandable Stents (lot 10153876) due to potential dislodgement during deployment, which may require additional intervention. Learn if your stent is affected and what to do.
Cook Inc.Apr 15, 2020 - Lower riskMedical device
Cook Inc. recalls Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order
Cook recalls Spectrum Central Venous Catheter Tray with incorrect printed expiration dates. This may lead to improper use of medical devices. Affected units include specific part numbers and lot numbers.
CookMar 6, 2020 - Lower riskMedical device
Cook Inc. recalls Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Cook recalls Zenith Alpha Spiral-Z Endovascular Leg grafts (catalog prefix ZISL) due to potential thrombus formation and lumen occlusion risks. Product not distributed in the USA.
CookJan 16, 2020 - Lower riskMedical device
Cook Inc. recalls Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6.
Cook recalls specific lots of Dawson-Mueller Drainage Catheter due to potential leakage from Mac-Loc hub assembly. Affected units may cause fluid buildup; contact for return or replacement.
CookDec 27, 2019 - Lower riskMedical device
Cook Inc. recalls CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular
Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque marker bands that could affect imaging during vascular procedures. Affected units include specific model numbers and lot numbers.
CookNov 8, 2019 - Lower riskMedical device
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system,
Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units may cause infection if used. Contact Cook for details.
CookOct 21, 2019 - Lower riskMedical device
Cook Inc. recalls Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Cook recalls Guardia Access Nano Embryo Transfer Catheters that may bend, causing difficulty inserting during IVF embryo transfers. Affected units may require repeat procedures or additional IV: cycles.
CookOct 3, 2019 - Lower riskMedical device
Cook Inc. recalls Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne
Cook recalls Pneumothorax Trays with Catalog No. C-UTPTY-1400-WAYNE-112497-IMH for potential sterility compromise in modified Wayne sets. Affected units may have lidstock perforation lines over sterile areas.
CookSep 17, 2019 - Use cautionMedical device
Cook Inc. recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number
Cook Inc. recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter due to balloons bursting below rated pressure, risking vessel injury or procedure delays. Affected units have specific lot numbers.
Cook Inc.May 24, 2019 - Lower riskMedical device
Cook Inc. recalls Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Cook recalls Neff Percutaneous Access Set (NPAS-10:00-RH-NT) due to potential missing bottom seal on packaging, risking unsterile use. Affected units sold with lot 8373482.
CookMay 2, 2019 - Use cautionMedical device
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70,
Cook recalls Zenith Alpha Abdominal Endovascular Grafts with specific part numbers due to potential damaged gray safety lock knob that may cause deployment issues during surgery. Affected units may require medical intervention.
CookApr 26, 2019 - Lower riskMedical device
Cook Inc. recalls Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0
Cook recalls specific ureteral stent sets due to missing warning for stent knotting. Affected models include 4.7 Fr, 6.0 Fr, and 7.0 Fr sizes with certain lot codes. No action is required as the hazard is not severe enough to warrant immediate stop use.
CookApr 22, 2019 - Lower riskMedical device
Cook Inc. recalls Thoracentesis Set, RPN C-THS-850, Order # G03286
Cook recalls Thoracentesis Set RPN C-THS-850 (Lot NS7662071) due to potential small catheter hole causing complications during medical procedures.
CookApr 9, 2019 - Use cautionMedical device
Cook Inc. recalls Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both
Cook recalls transseptal needles with missing back bevel that could damage heart introducer during procedure. Affected models include TSNC-18-71.0 (Order G02364).
CookFeb 1, 2019 - Use cautionMedical device
Cook Inc. recalls Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877
Cook recalls Universa Firm Ureteral Stents with specific product numbers due to risk of stiff wire guide tip entering patients during insertion.
CookJan 4, 2019 - Lower riskMedical device
Cook Inc. recalls Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Cook recalls Check-Flo Performer Introducer with longer sheaths that may cause injury during use. Affected units include specific catalog and lot numbers. Consumers should contact Cook for details.
CookDec 21, 2018 - Lower riskMedical device
Cook Inc. recalls Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure
Cook recalls Entuit Secure Gastrointestinal Suture Anchor Sets with specific lot numbers due to potential difficulty sliding down the retention mechanism. Affected units may require replacement to prevent complications during medical procedures.
CookDec 19, 2018 - Stop using nowMedical device
Cook Inc. recalls VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular
Cook recalls VentriClear Ventricular Drainage Catheter Set (lot : 8639185) due to endotoxin testing failure. This may cause immune reactions from mild fever to life-threatening systemic inflammation.
CookMay 31, 2018 - Lower riskMedical device
Cook Inc. recalls Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0;
Cook recalls Advance 35LP Low-Profile PTA Balloon Dilatation Catheters with incorrect balloon size labels. Product labeled as 6mm x 2cm may have a 4mm x 4cm balloon, causing potential misuse during medical procedures.
CookApr 16, 2018 - Use cautionMedical device
Cook Inc. recalls Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a
Cook recalls HPCT8.8-60-M-FM-BNS connecting tubes for potential fluid leakage during angiography procedures. Affected units may cause air aspiration or fluid leakage if the cap-adapter assembly isn't properly tightened.
CookMar 29, 2018 - Use cautionMedical device
Cook Inc. recalls Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and
Cook recalls vacuum pumps K-MAR-5200-US model for potential electric shock or failure due to improper wiring. Affected units may need repair or replacement.
CookMar 22, 2018 - Lower riskMedical device
Cook Inc. recalls StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Cook recalls StoneBreaker Exhaust Caps due to potential inadequate sterilization during reprocessing, affecting all units sold. Consumers should check product details and contact Cook for guidance.
CookJan 31, 2018 - Lower riskMedical device
Cook Inc. recalls MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed,
Cook Inc. recalls MINC Benchtop Incubators due to potential temperature fluctuations in incubation lids that could affect cell culture results. Affected units may need repair or replacement.
Cook Inc.Jan 12, 2018 - Lower riskMedical device
Cook Inc. recalls Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in
Cook recalls Norm-Ject Tuberkulin Syringes (Catalog K-ATS-1000) used in IVF procedures due to potential nonviable gametes or embryos from incomplete quality testing.
CookDec 19, 2017 - Use cautionMedical device
Cook Inc. recalls Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a
Cook recalls Mallinckrodt Institute Percutaneous Gastrostomy Sets with backward-loaded wire guides. Affected lots include 6869315, 6908857, 7034661, 7106057, 7193431, 7252317, 7635697, 7744001, 7811587, 8025220, 8076495. Contact Cook for remedy.
CookOct 19, 2017 - Lower riskMedical device
Cook Inc. recalls Coons Interventional Wire Guide
Cook recalls Coons Interventional Wire Guides with heparin coating not labeled. Affected units have specific lot codes. Contact for details.
CookOct 13, 2017 - Lower riskMedical device
Cook Inc. recalls Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central
Cook recalls Central Venous Tray Triple Lumen Polyurethane Catheter (C-UTLMY-501J-CCT) due to possible procedure delays if not fitting over guide wire. Affected units sold to hospitals and critical care facilities.
CookJul 31, 2017
Cook Inc. recall questions
How many recalls has Cook Inc. had?
206 recalls from Cook Inc. are on record with U.S. safety agencies, from 2017–2021.
What is the most recent Cook Inc. recall?
Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155, dated Nov 12, 2021. Every Cook Inc. recall is listed on this page, newest first.
Why are Cook Inc. products recalled?
The most common reasons on record: Label does not state that the product is heparin-coated. (20); The printed expiration dates are incorrect. (2).
What should I do if I have a recalled Cook Inc. 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 Inc. 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.