Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 3, 2025
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Reason: Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Root cause: Process control
Recalling firm: Becton, Dickinson and Company, BD Bio SciencesType: Counter, Differential CellDistribution: US: Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Hong Kong, India, Japan, South Korea, Mexico, Malaysia, Nepal, New Zealand, Peru, Pakistan, Singapore, El Salvador, Taiwan
OUS:Recall #Z-2078-2025
Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 3, 2025
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Reason: Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Root cause: Process control
Recalling firm: Becton, Dickinson and Company, BD Bio SciencesType: Counter, Differential CellDistribution: US: Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Hong Kong, India, Japan, South Korea, Mexico, Malaysia, Nepal, New Zealand, Peru, Pakistan, Singapore, El Salvador, Taiwan
OUS:Recall #Z-2079-2025
Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 4, 2025
ADVIA 120/2120/2120i SETpoint Calibrator
Reason: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Calibrator For Hemoglobin And Hematocrit MeasurementDistribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.Recall #Z-2086-2025 Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 4, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Reason: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Control, Cell Counter, Normal And AbnormalDistribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.Recall #Z-2087-2025 Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 4, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Reason: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Control, Cell Counter, Normal And AbnormalDistribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.Recall #Z-2088-2025 Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 4, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Reason: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Control, Cell Counter, Normal And AbnormalDistribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.Recall #Z-2089-2025 Open, ClassifiedPosted Jul 2, 2025·Initiated May 9, 2025
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Reason: This device does not indicate for use in patients with respiratory failure.
Root cause: Device Design
Recalling firm: Philips Respironics, Inc.Type: Ventilator, Continuous, Non-Life-SupportingDistribution: Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).Recall #Z-2035-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 9, 2025
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg.
BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
Reason: This device does not indicate for use in patients with respiratory failure.
Root cause: Device Design
Recalling firm: Philips Respironics, Inc.Type: Ventilator, Continuous, Non-Life-SupportingDistribution: Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).Recall #Z-2036-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 9, 2025
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
BiPAP A40 Pro - sold OUS
Reason: This device does not indicate for use in patients with respiratory failure.
Root cause: Device Design
Recalling firm: Philips Respironics, Inc.Type: Sv70 VentilatorDistribution: Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).Recall #Z-2037-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips 3D9-3v Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2048-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips C5-1 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2049-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips C5-2 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2050-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips C9-5EC Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2051-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips eL18-4 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2052-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips eL18-4 EMT Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2053-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips L12-3 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2054-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips L12-4 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2055-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips L8-4 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2056-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips L9-3 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2057-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips S5-1 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2058-2025