🔍 RecallPedia

All Recalls

95,114 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,667
Consumer Products

Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Cook

🏥 Medical Devices Class I - Dangerous

Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

Jul 2, 2015 Surgical Instruments Nationwide View Details →

Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Jun 29, 2015 Diagnostic Equipment Nationwide View Details →

Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Cook

🏥 Medical Devices Class I - Dangerous

Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

Jul 2, 2015 Surgical Instruments Nationwide View Details →

Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Jun 29, 2015 Diagnostic Equipment Nationwide View Details →

Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.

Philips Electronics North America

🏥 Medical Devices Class I - Dangerous

Multiple software and hardware issues with device that can affect its function.

Jun 5, 2015 Diagnostic Equipment Nationwide View Details →

Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.

Olympus Scientific Solutions Americas

🏥 Medical Devices Class I - Dangerous

Higher than published scatter around the probe head when testing some samples. At the point the customer would interact directly with the instrument (Trigger position), most readings were lower. However, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum).

Jun 9, 2015 Other Medical Devices Nationwide View Details →

S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.

Roche Diagnostics Operations

🏥 Medical Devices Class I - Dangerous

The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.

Jun 24, 2015 Diagnostic Equipment View Details →

Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.

Medtronic Navigation

🏥 Medical Devices Class I - Dangerous

The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window in the brain.

Jul 17, 2015 Surgical Instruments Nationwide View Details →

Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Cook

🏥 Medical Devices Class I - Dangerous

Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

Jul 2, 2015 Surgical Instruments Nationwide View Details →

30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

Zimmer Surgical

🏥 Medical Devices Class I - Dangerous

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Jun 24, 2015 Surgical Instruments Nationwide View Details →

Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.

TITAN SPINE

🏥 Medical Devices Class I - Dangerous

Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.

Jul 20, 2015 Implants & Prosthetics View Details →

Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Jun 29, 2015 Diagnostic Equipment Nationwide View Details →