Cook Inc.
188 recalls on record · Latest: Dec 29, 2021
Cook Inc. Recall Insight
Cook Inc. appears on 188 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.224% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 29, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 50 entries, severity tagging shows 21 critical, 29 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Nov 27, 2019 to Dec 29, 2021.
Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of …
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeuti…
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and…
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydro…
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding S…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding S…
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduc…
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduc…
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To ass…
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aort…
Pressure Monitoring Set, C-PMS, G02838
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G498…
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
Wire Guide, Guidewire, Global Product Number G14326
Urethral Dilator Set, Global Product No. G14185
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G499…
Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLD…
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…
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