Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 21, 2025
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
Reason: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Root cause: Device Design
Recalling firm: GE Medical Systems China Co., Ltd.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tonga, Trinidad Tobago, Tunisia, T¿rkiye, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.Recall #Z-1638-2025
Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 19, 2025
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Reason: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Root cause: Process control
Recalling firm: Siemens Healthcare Diagnostics IncType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Malaysia, Mali, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam.Recall #Z-1684-2025 Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 19, 2025
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Reason: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Root cause: Process control
Recalling firm: Siemens Healthcare Diagnostics IncType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Malaysia, Mali, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam.Recall #Z-1685-2025 Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 24, 2025
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.
The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Reason: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Cryosurgical, AccessoriesDistribution: NationwideRecall #Z-1686-2025 Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 24, 2025
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100.
The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Reason: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Cryosurgical, AccessoriesDistribution: NationwideRecall #Z-1687-2025 Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 24, 2025
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170.
The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Reason: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Cryosurgical, AccessoriesDistribution: NationwideRecall #Z-1688-2025 Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 24, 2025
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170.
The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Reason: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Cryosurgical, AccessoriesDistribution: NationwideRecall #Z-1689-2025 Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 18, 2025
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
Reason: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that
product information (labelling and instructions for use) should be provided in all three official
languages of Switzerland (German, French, and Italian).
Root cause: Process control
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: International Only: Switzerland.Recall #Z-1690-2025
Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 18, 2025
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
Reason: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that
product information (labelling and instructions for use) should be provided in all three official
languages of Switzerland (German, French, and Italian).
Root cause: Process control
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: International Only: Switzerland.Recall #Z-1691-2025
Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 18, 2025
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1(German/English dual language), DCF-E2310E3/1(German/French dual language), DCF-E2310F3/1 (French/English dual language), DCF-E2310G3/1(French/German dual language), DCF-E2310IT (Italian language)
Reason: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that
product information (labelling and instructions for use) should be provided in all three official
languages of Switzerland (German, French, and Italian).
Root cause: Process control
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: International Only: Switzerland.Recall #Z-1692-2025
Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 18, 2025
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Reason: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that
product information (labelling and instructions for use) should be provided in all three official
languages of Switzerland (German, French, and Italian).
Root cause: Process control
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: International Only: Switzerland.Recall #Z-1693-2025
Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 18, 2025
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
Reason: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that
product information (labelling and instructions for use) should be provided in all three official
languages of Switzerland (German, French, and Italian).
Root cause: Process control
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: OUS only: Switzerland.Recall #Z-1694-2025
Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 19, 2025
Brand Name: Quantum Informatics - VIPER
Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)
Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.
Reason: Medical device software marketed without FDA clearance .
Root cause: No Marketing Application
Recalling firm: Spectrum Medical Ltd.Type: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Minnesota, Distric of Columbia, Ohio, Conneticut, New Jersey, Utah, North Carolina, Louisiana, Kentucky, New York, Kansas, South Carolina, Idaho, Tennessee, Oregon, Maine, Indiana, Oklahoma, New Mexico, North Dakota, Alabama, Michigan, MississippiRecall #Z-1695-2025
Open, ClassifiedPosted Apr 29, 2025·Initiated Mar 19, 2025
Brand Name: Quantum Informatics - VISION / LIVE VUE
Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)
Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.
Reason: Medical device software marketed without FDA clearance .
Root cause: No Marketing Application
Recalling firm: Spectrum Medical Ltd.Type: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Minnesota, Distric of Columbia, Ohio, Conneticut, New Jersey, Utah, North Carolina, Louisiana, Kentucky, New York, Kansas, South Carolina, Idaho, Tennessee, Oregon, Maine, Indiana, Oklahoma, New Mexico, North Dakota, Alabama, Michigan, MississippiRecall #Z-1696-2025
Open, ClassifiedPosted Apr 28, 2025·Initiated Mar 26, 2025
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.
Reason: An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser
safety Class 2 classification.
Root cause: Under Investigation by firm
Recalling firm: Trimble AbType: Surveying Laser ProductDistribution: US and OUS (South Korea and United Kingdom).Recall #Z-1661-2025
Open, ClassifiedPosted Apr 28, 2025·Initiated Apr 2, 2025
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0.
The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
Reason: There is a leakage issue associated with the tubing in the manifold of the instrument.
Root cause: Release of Material/Component prior to receiving test results
Recalling firm: Leica Biosystems Melbourne Pty LtdType: Processor, Tissue, AutomatedDistribution: US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.Recall #Z-1683-2025
Open, ClassifiedPosted Apr 25, 2025·Initiated Mar 17, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:
C63519 / 14987666545058
C63520 / 14987666545065
Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3
The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Reason: The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Root cause: Under Investigation by firm
Recalling firm: Beckman Coulter Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, CA, CO, GA, ID, IL, IN, LA, MA, MI,MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI. The countries of Australia, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Egypt, Ethiopia, France, Georgia, Germany, Ghana, India, Italy, Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Puerto Rico, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain, Switzerland, and Tunisia.Recall #Z-1672-2025
Open, ClassifiedPosted Apr 25, 2025·Initiated Mar 31, 2025
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Reason: Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics IncType: Fluorometric Method, Cpk Or IsoenzymesDistribution: Worldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO, NJ, NY, OH, OK, PA, SC & WI. The countries of Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland & Vietnam.Recall #Z-1673-2025 Open, ClassifiedPosted Apr 25, 2025·Initiated Mar 31, 2025
Hyperthermia Pump Procedure Kit. Model Number: 902-00045.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedure Pack (P/N 902-00048P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).
Reason: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Root cause: Process design
Recalling firm: Belmont Instrument LLCType: Warmer, Thermal, Infusion FluidDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.Recall #Z-1674-2025
Open, ClassifiedPosted Apr 25, 2025·Initiated Mar 31, 2025
Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Outflow Patient Line (P/N 902-00039P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).
Reason: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Root cause: Process design
Recalling firm: Belmont Instrument LLCType: Warmer, Thermal, Infusion FluidDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.Recall #Z-1675-2025