Cook
41 federal recalls on file, showing the 21 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Cook and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-15FDA-DeviceClass IICheck expiration dates on Cook Medical pneumothorax trays
Cook Medical's Wayne Pneumothorax Tray kits in certain lots were labeled with expiration dates that go beyond when the devices are actually safe to use. This affects 318 units distributed worldwide. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical pneumothorax kit expiration date
Cook Medical's Wayne Pneumothorax Set (certain lot numbers) was labeled with expiration dates that go beyond when the device is actually safe to use. This affects 104 units distributed worldwide. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical chest tube tray expiration dates
Cook Medical's Thal-Quick Chest Tube Tray (model C-TQTSY-3200) from two affected lots was labeled with expiration dates longer than the actual shelf life of the product. This means the sterile chest tube trays may not remain safe to use after their true expiration date has passed.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical central venous trays expiration dates
Cook Medical Spectrum Central Venous Trays from certain lots were labeled with expiration dates longer than the products' actual shelf life. This means some trays marked as safe to use may have degraded beyond their true usable period. Approximately 2,348 units are affected across multiple lot numbers.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical Spectrum catheter expiration dates
Cook Medical Spectrum Central Venous Catheter Sets in certain lots were labeled with expiration dates that go beyond their actual shelf life. This means some catheters may have degraded beyond their labeled date of use. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical stone extractor expiration dates
Cook Medical's NCompass Nitinol Stone Extractor devices in certain lots were labeled with expiration dates that go beyond the actual shelf life of the product. This affects 70 units distributed worldwide. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical drainage catheter expiration date
Cook Medical multipurpose drainage catheters from two specific lots were labeled with expiration dates that go beyond their actual safe shelf life. This means catheters could be used after they are no longer guaranteed to be sterile or safe. The affected catheters were distributed worldwide, and 20 units are involved.
- 2026-04-15FDA-DeviceClass IICheck Cook Melker catheter set expiration dates
Cook Incorporated discovered that certain lots of the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set were labeled with expiration dates longer than the actual shelf life of the product. This means some units may have been used past their true expiration date, potentially affecting sterility and safety.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical bile duct exploration kit expiration
Cook Medical's Strange Bile Duct Stone Exploration Set (model C-CSRC-7.5D-40-STRANGE) in five specific lot numbers has been labeled with expiration dates that are longer than the device's actual shelf life. This means the device may degrade or fail before the printed date suggests it should.
- 2026-04-15FDA-DeviceClass IICheck Cook Spectrum catheter tray expiration date
Cook Medical issued a recall of certain Spectrum Central Venous Catheter Tray units because the labels show expiration dates that are longer than the actual shelf life of the product. This means some trays labeled as usable may have actually expired. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical extubation set expiration dates
Cook Medical's Staged Extubation Set (Part Number C-CAE-14.0-83-EXTU, Lot 16010654) was labeled with expiration dates that go beyond when the device is actually safe to use. About 95 units were distributed worldwide. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical tracheostomy introducer expiration dates
Cook Medical's Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set in certain lots has been labeled with expiration dates that extend beyond the actual shelf life of the product. This affects 484 units distributed worldwide. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck expiration dates on Cook Medical Blue Rhino tracheostomy kits
Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray was labeled with expiration dates that are longer than the actual shelf life of the product. This affects specific lot numbers distributed worldwide. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical tracheostomy introducer expiration dates
Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set from certain lots was labeled with expiration dates longer than the actual shelf life of the device. This means some units may have degraded before their printed expiration date, potentially affecting performance when used.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical monitoring trays for expiration date
Cook Medical arterial pressure monitoring trays in three specific lots were labeled with expiration dates that go beyond their actual shelf life. This means the devices may not perform as expected if used after their true expiration. Twenty units were affected and distributed worldwide.
- 2026-04-15FDA-DeviceClass IICOOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical wire guide expiration dates
Cook Medical's Approach CTO-12 Micro Wire Guide devices in three affected lots have expiration dates printed on the packaging that go beyond when the devices actually expire. This could lead to use of degraded or ineffective devices. No injuries have been reported.
- 2026-04-15FDA-DeviceClass IICheck Cook Medical wire guide expiration dates
Cook Medical's Approach CTO-6 Micro Wire Guide (Part CMW-14-190-6G, Lot 15288005) was labeled with expiration dates that go beyond when the device actually expires. This means the device may no longer be safe or effective to use after the true expiration date, even though the label says it is still good.
- 2025-12-31FDA-DeviceClass IIContact Cook Medical about liver access device
Cook Medical recalled Rösch-Uchida Transjugular Liver Access Sets (part number RUPS-100) used in liver procedures because some units were manufactured incorrectly. Affected devices may have been cut to the wrong length, not properly trimmed, or not inspected. Only 23 units were affected worldwide.
- 2025-12-31FDA-DeviceClass IICheck Cook Ring Transjugular Access Sets for defects
Cook Medical found that certain Ring Transjugular Intrahepatic Access Sets used in liver procedures were manufactured incorrectly. Affected devices may have been cut to the wrong length, trimmed improperly, or not inspected properly before shipment. This involves 15 units distributed worldwide.
- 2025-12-31FDA-DeviceClass IICheck Flexor introducer lot numbers immediately
Cook Medical recalled certain Flexor Check-Flo Introducer and Set models because some units were manufactured out of specification. Affected devices may have been cut to incorrect lengths, not properly trimmed, or not inspected properly. This is a medical device used in vascular procedures.
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