Surgical Equipment

Steris Surgical Monitor Accessories Recalled for Risk of Detachment

• Distributed nationwide
• Sold at Direct sales, Authorized medical equipment distributors

Getinge Usa Sales Inc: ALPHAMAXX Mobile Operating Tables Recalled Due to Charger Defect

• Sold in 4 states
• Sold at Authorized Medical Distributors, Getinge USA Sales Inc.

Stryker, Inc.: Trevo Pro 18 and Trak 21 Microcatheters Recalled for Unapproved Instructions

• Sold in 12 states
• Sold at Stryker, Inc. direct distribution

Codman Surgical Patties and Strips Recalled for High Endotoxin Levels

• Distributed nationwide
• Sold at Authorized medical distributors, Hospitals +1 more
• Endotoxin contamination

Baxter TruSystem 7000 Operating Tables Recalled for Battery Short-Circuit

• Distributed nationwide
• Sold at Direct Sales, Medical Equipment Distributors
• Customer reports of electrical short-circuits and emitted smoke; no specific injury counts mentioned.

Olympus Biopsy Valves Recalled for Potential Rubber Fragment Detachment

• Distributed nationwide
• Sold at Authorized distributors, Medical supply channels
• 97,158 units affected

Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance

• Sold in 34 states
• Sold at Authorized Medical Distributors, Healthcare Facilities
• 29,500 units affected

MEDLINE INDUSTRIES, LP - Northfield: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.; XXX

Olympus Corporation of the Americas: Veran Navigation Systems and Instruments Recalled for Design Non-conformances

• Distributed nationwide
• Sold at Hospitals and medical facilities
• 83,613 units affected

Merit Medical Inflation Devices Recalled for Sterile Barrier Defects

• Sold in 48 states
• Sold at Hospital supply distributors, Direct medical sales +1 more
• Pathogens, Pyrogens contamination

Stryker Otopore, Nasopore, and Hemopore Dressings Recalled for Sterile Seal Breach

• Distributed nationwide
• Sold at Authorized medical distributors, Hospitals +1 more
• Microbial contamination risk due to seal breach contamination

Olympus Bronchoscopes Recalled for Thermal Therapy Safety Updates

• Distributed nationwide
• Sold at Hospital supply distributors, Direct sales to medical facilities
• 19,457 units affected

Cardiac Assist, Inc: LifeSPARC Pumps Recalled for Potential Early Failure Due to Uncured Epoxy

• Sold in Illinois, Florida
• Sold at Hospitals and Specialized Medical Facilities
• Uncured epoxy contamination

American Contract Systems, Inc.: Surgical and Medical Packs Recalled for Sterilization Error

• Sold in Florida, Iowa
• Sold at Hospitals and medical facilities
• Ethylene Oxide contamination

Frontier Devices Distraction Pins Recalled for Unvalidated Shelf Life

• Sold in 9 states
• Sold at Hospitals, Surgical Centers +1 more
• 18,100 units affected

Merit Medical EsophyX Z+ Delivery Devices Recalled for Safety Update

• Sold in 44 states
• Sold at Hospitals, Surgical Centers +1 more

Lumicell Sterile Covers Recalled for Detaching Elastic Band Risk

• Sold in 5 states
• Sold at Surgical Centers, Hospitals
• Foreign body (elastic band fragments) contamination

North American Rescue JETT Device Recalled for Potential Manufacturing Defect

• Sold in 29 states
• Sold at Authorized distributors, Specialty medical retailers

GE Medical Systems, LLC: Tec 6 Plus and Tec 800 Series Anesthesia Vaporizers Recalled for Low Output

• Distributed nationwide
• Sold at GE Medical Systems, LLC, Authorized medical device distributors
• 13,058 units affected

Smith & Nephew BIOSURE HA Screws Recalled for Labeling Error

• Sold in 15 states
• Sold at Hospitals, Surgical Centers +1 more

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.

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

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

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