Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Reason: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Device, Positive Pressure Breathing, IntermittentDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-2549-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Reason: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Device, Positive Pressure Breathing, IntermittentDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-2550-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Reason: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Device, Positive Pressure Breathing, IntermittentDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-2551-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Reason: Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of PA, GA, CA, WA.Recall #Z-2619-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Reason: Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of PA, GA, CA, WA.Recall #Z-2620-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Reason: Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of PA, GA, CA, WA.Recall #Z-2621-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Reason: Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of PA, GA, CA, WA.Recall #Z-2622-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 22, 2026
IntelliCuff, Portable automatic cuff pressure controller
REF: 951001
Reason: Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
Root cause: Process design
Recalling firm: Hamilton Medical AGType: Cuff, Tracheal Tube, InflatableDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.Recall #Z-2625-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Pro Wireguided 6-8mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Stents, Drains And Dilators For The Biliary DuctsDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2626-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Pro Wireguided 8-10mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Stents, Drains And Dilators For The Biliary DuctsDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2627-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Pro Wireguided 10-12mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Stents, Drains And Dilators For The Biliary DuctsDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2628-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Pro Wireguided 12-15mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Stents, Drains And Dilators For The Biliary DuctsDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2629-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Pro Wireguided 15-18mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Stents, Drains And Dilators For The Biliary DuctsDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2630-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Pro Wireguided 18-20mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Stents, Drains And Dilators For The Biliary DuctsDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2631-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Wireguided 6-8mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Duodenoscope And Accessories, Flexible/RigidDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2632-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Wireguided 8-10mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Duodenoscope And Accessories, Flexible/RigidDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2633-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Wireguided 10-12mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Duodenoscope And Accessories, Flexible/RigidDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2634-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Wireguided 12-15mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Duodenoscope And Accessories, Flexible/RigidDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2635-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Wireguided 15-18mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Duodenoscope And Accessories, Flexible/RigidDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2636-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 21, 2026
CRE Wireguided 18-20mm 240cm
Reason: Potential sterile breach of the pouches in which devices are packaged.
Root cause: Package design/selection
Recalling firm: Boston Scientific CorporationType: Duodenoscope And Accessories, Flexible/RigidDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.Recall #Z-2637-2026