Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-09-21FDA-DeviceICU Medical, Inc.Class II6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- 2022-09-21FDA-DeviceICU Medical, Inc.Class II6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- 2022-09-21FDA-DeviceICU Medical, Inc.Class IIMicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- 2022-09-21FDA-DeviceICU Medical, Inc.Class II6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- 2022-09-21FDA-DeviceICU Medical, Inc.Class II8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- 2022-09-21FDA-DeviceICU Medical, Inc.Class IIMicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceCook IncorporatedClass IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 2022-09-21FDA-DeviceBaxter Healthcare CorporationClass IBaxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Firm noted an increase in customer reports of leaks.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious eye packs, cataract packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IID&C pack
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious C-section packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious hysterectomy, vaginal packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious ob/gyn packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious neurology packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious convenience packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious convenience packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIBreast Abdominoplasty Pack
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious Port Insertion Packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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