Medical Devices

Olympus Corporation of the Americas: EZDilate Balloons Recalled for Bursting and Deflation Issues

• Distributed nationwide
• Sold at Olympus Corporation, Specialty medical distributors
• Reports of device bursting, leaking, foreign bodies left in patients, and prolonged procedures.

BD Pyxis Automated Dispensing Cabinets Recalled for Software Bug

• Sold in 49 states
• Sold at Clinical settings, Healthcare facilities

Baxter Healthcare Corporation: Seprafilm Adhesion Barrier Recalled for Lack of Regulatory Approval

• Sold in 7 states
• Sold at hospitals, surgical centers

GE Medical Systems, LLC: OEC Elite and OEC 3D Mobile C-Arms Recalled for Excessive X-ray Exposure

• Distributed nationwide
• Sold at Authorized GE Medical Systems distributors, Medical device supply channels

Intuitive Surgical Reusable Instruments Recalled for Broken Grip Cables

• Distributed nationwide
• Sold at Intuitive Surgical Authorized Distributors, Hospitals +1 more
• Metal fragments contamination

Medline Surgical Patties and Strips Recalled for High Endotoxin Levels

• Distributed nationwide
• Sold at Hospitals, Surgical Centers +1 more
• Endotoxin contamination

UNiD Adaptive Spine Intelligence Recalled for Incorrect Surgical Calculations

• Sold in 50 states
• Sold at Hospitals, Surgical Centers

Advance Medical Designs, Inc.: Ultrasound Gel and Procedural Kits Recalled for Mislabeled Inappropriate Use

• Distributed nationwide
• Sold at Advance Medical Designs, Inc., Medical Supply Distributors
• 160,865 units affected

Philips MR Systems Recalled for Gradient Coil Component Fire Risk

• Distributed nationwide
• Sold at hospitals, imaging centers +1 more

3M Ranger Blood/Fluid Warming High Flow Sets Recalled to Clarify Safety

• Distributed nationwide
• Sold at Medical distributors, Direct healthcare facility sales
• 530,470 units affected

Merit Medical Systems, Inc.: Microcatheter and Infusion Systems Recalled for Lack of Sterility Assurance

• Sold in 20 states
• Sold at Authorized Medical Distributors, Direct Hospital Sales

GE Healthcare: Centricity PACS and Universal Viewer Software Recalled for Patient Data Mix-ups

• Distributed nationwide
• Sold at Authorized GE HealthCare medical device distributors, Direct sales to hospitals and clinics

Medline Kits with BD SureStep Foley Trays Recalled for Mislabeled Inserts

• Sold in Florida, Illinois
• Sold at Hospitals, Surgical Centers

Abbott GmbH: Anti-HCV Reagent Kits Recalled for Falsely Elevated Patient Results

• Distributed nationwide
• Sold at Abbott GmbH, Medical laboratories +1 more
• 12,329 units affected

Karl Storz Endoscopes Recalled Due to Unapproved Reprocessing Instructions

• Distributed nationwide
• Sold at Authorized Medical Distributors

ID NOW COVID-19, Flu, and RSV Test Kits Recalled for High Invalid Result Rates

• Distributed nationwide
• Sold at Authorized distributors, Point-of-care facilities
• 5,383,584 units affected

Smiths Medical ASD Inc.: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

MEDLINE INDUSTRIES, LP - Northfield: Medical Convenience Kits Recalled Due to Faulty Plastic Syringes

• Distributed nationwide
• Sold at Authorized Medical Distributors, Hospitals +1 more

Cardiosave Intra-Aortic Balloon Pumps Recalled for Software Correction

• Distributed nationwide
• Sold at Direct sales, Medical device distributors

Cardinal Health 200, LLC: Monoject Syringes Recalled for Infusion Pump Compatibility Issues

• Sold in 44 states
• Sold at medical supply distributors
• 16,602,596 units affected

K-Systems Incubators and Warming Plates Recalled for Excessive Temperatures

• Sold in 8 states
• Sold at Authorized medical device distributors, CooperSurgical

Karl Storz Endoscopy: Grasping Forceps, Scissors, and Retractors Recalled for Cleaning Safety Concerns

• Sold in 25 states
• Sold at Karl Storz Endoscopy, Authorized Medical Distributors

GE Healthcare MR Imaging Systems Recalled for Potential Overheating Risk

• Distributed nationwide
• Sold at GE Healthcare, Authorized Medical Device Distributors

Olympus Corporation of the Americas: ENDOEYE FLEX Deflectable Videoscopes Recalled Due to Reprocessing Errors

• Distributed nationwide
• Sold at Authorized Medical Distributors, Direct Sales