Cook Recalls

24 recalls found for Cook. Check if any of your products are affected.

HIGH
FDA DEVICE

Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials...

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

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HIGH
FDA DEVICE

Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in...

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

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HIGH
FDA DEVICE

Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 ...

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

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Marker bands
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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Wayne Pneumothorax Set Recalled for Expired Shelf Life Labels

Cook Incorporated recalls 104 Wayne Pneumothorax Sets worldwide after labeling errors show expiration dates exceeding true shelf life. The recall affects reference parts C-UTPT-1020-WAYNE-IMH and C-UTPT-1400-WAYNE-112497-IMH with order numbers G56532 and G56535. Healthcare providers should stop use immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Thal-Quick Chest Tube Tray Recalled for Expiration Dates Exceeding Shelf Life

Cook Medical recalled the Thal-Quick Chest Tube Tray, reference part number C-TQTSY-3200, Order G07242, due to expiration dates that exceed true shelf life. The recall is active and worldwide. The hazard is labeling that misstates shelf life. Patients and healthcare providers should stop using the affected devices immediately and follow Cook’s recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Blue Rhino G2-Multi Tracheostomy Introducer Set Recalled for Expiration Date Labeling —

Cook Medical recalled 916 units of the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set worldwide after discovering expiration dates exceeded true shelf life. The recall affects multiple reference part numbers and order numbers. Healthcare providers should stop using the device immediately and follow Cook’s instructions for recall notification.

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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical NCompass Nitinol Stone Extractor Recalled Over Expiration Date Shelf-Life Concerns (202

Cook Medical recalled 70 NCompass nitinol stone extractors worldwide after labeling showed expiration dates that exceed their true shelf life. The recall affects lots labeled C-NTSE-2.4-115-NC3 (G36250) and C-NTSE-2.4-115-NCT4 (G36251). The company classifies the action as Class II and says the issue could affect patient safety.

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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Approach CTO-12 Micro Wire Guide Recall Affects 49 Units for Expired Shelf-Life Labels

Cook Medical recalled 49 units of the Approach CTO-12 Micro Wire Guide due to expiration dates that exceed the true shelf life. The recall covers two reference part numbers and multiple lots distributed worldwide. Healthcare providers and patients should stop using the affected devices immediately. Follow the manufacturer’s recall instructions or contact a healthcare provider for guidance.

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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Recall: Cook Staged Extubation Set Labeled with Expired Dates in 2026 Class II Recall

Cook Medical issued a global recall of 95 units of the Cook Staged Extubation Set due to expiration dates that exceed true shelf life. The affected lots carry Reference Part Number C-CAE-14.0-83-EXTU and Order Number G24073. The recall is classified as HIGH hazard. Patients and healthcare providers should stop using the device immediately and follow recall instructions from Cook Incorporated.

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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray Recalled Over Expired-Lot

Cook Incorporated recalled 441 units of the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray after identifying expiration dates that exceed true shelf life. The recall covers lots with Reference Part Numbers C-PTISY-100-HC-G-NA, C-PTISY-100-UNL-HC-G-NA and C-PTISY-100-UNS-HC-G-NA distributed worldwide. Healthcare providers must stop use and follow manufacturer recall instructions.

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Brand Statistics

Total Recalls
24
Pages
2

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