CompletedPosted Oct 24, 2025·Initiated Sep 16, 2025
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Root cause: Under Investigation by firm
Recalling firm: Surgical Theater IncType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.Recall #Z-0320-2026
CompletedPosted Oct 24, 2025·Initiated Sep 16, 2025
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Root cause: Under Investigation by firm
Recalling firm: Surgical Theater IncType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.Recall #Z-0321-2026
CompletedPosted Oct 24, 2025·Initiated Sep 16, 2025
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Root cause: Under Investigation by firm
Recalling firm: Surgical Theater IncType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.Recall #Z-0322-2026
CompletedPosted Oct 24, 2025·Initiated Sep 16, 2025
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Root cause: Under Investigation by firm
Recalling firm: Surgical Theater IncType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.Recall #Z-0323-2026
CompletedPosted Oct 24, 2025·Initiated Sep 16, 2025
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Root cause: Under Investigation by firm
Recalling firm: Surgical Theater IncDistribution: Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.Recall #Z-0324-2026
CompletedPosted Oct 24, 2025·Initiated Sep 16, 2025
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Root cause: Under Investigation by firm
Recalling firm: Surgical Theater IncType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.Recall #Z-0325-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Sep 30, 2025
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Reason: Potential for a weak seal in some units resulting in compromise in sterility.
Root cause: Process control
Recalling firm: Alcon Research LLCType: Lenses, Soft Contact, Daily WearDistribution: Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.Recall #Z-0326-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Oct 16, 2025
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Reason: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
Root cause: Device Design
Recalling firm: Canon Medical System, USA, INC.Type: System, Nuclear Magnetic Resonance ImagingDistribution: US distribution to Ohio and NevadaRecall #Z-0327-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Oct 2, 2025
IV Administration sets.
23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359;
23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213;
70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732;
80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733;
53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
Reason: IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
Root cause: Process control
Recalling firm: ICU Medical, Inc.Type: Stopcock, I.V. SetDistribution: Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.Recall #Z-0154-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Aug 5, 2025
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor;
Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor
Reason: A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Root cause: Software change control
Recalling firm: Tandem Diabetes Care, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: US nationwide distribution including Puerto Rico.Recall #Z-0232-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 17, 2025
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
Reason: Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Continuous Measurement ThermometerDistribution: Distribution US nationwide, Canada and Colombia.Recall #Z-0233-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 11, 2025
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Reason: Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Root cause: Process control
Recalling firm: Medline Industries, LPType: Saline, Vascular Access FlushDistribution: Distribution US nationwide and CanadaRecall #Z-0234-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 23, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following:
1. Computer System Epicenter F/G, Catalog Number: 441002.
2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421.
3. Generic NUC 2, Catalog Number: 445398.
4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Root cause: Software design
Recalling firm: Becton Dickinson & Co.Type: Calculator/Data Processing Module, For Clinical UseDistribution: Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.Recall #Z-0235-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 23, 2025
BD BACTEC Blood Culture System, labeled as the following:
1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509.
2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676.
3. BACTEC 9240 System, Catalog Number: 445569.
4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Root cause: Software design
Recalling firm: Becton Dickinson & Co.Type: System, Blood CulturingDistribution: Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.Recall #Z-0236-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 23, 2025
BD BACTEC Blood Culture System, labeled as the following:
1. BACTEC 9120 System, Catalog Numbers: 445570, 445702.
2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Root cause: Software design
Recalling firm: Becton Dickinson & Co.Type: System, Blood CulturingDistribution: Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.Recall #Z-0237-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 23, 2025
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following:
1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Root cause: Software design
Recalling firm: Becton Dickinson & Co.Type: C. Difficile Toxin Gene Amplification AssayDistribution: Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.Recall #Z-0238-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 23, 2025
BD Phoenix M50 Instrument, labeled as the following:
1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Root cause: Software design
Recalling firm: Becton Dickinson & Co.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.Recall #Z-0239-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 23, 2025
BD Veritor Connect Software, labeled as the following:
1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Root cause: Software design
Recalling firm: Becton Dickinson & Co.Type: Colorimeter, Photometer, Spectrophotometer For Clinical UseDistribution: Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.Recall #Z-0240-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 29, 2025
Zenition 50;
Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Reason: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Root cause: Process control
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.Recall #Z-0241-2026
Open, ClassifiedPosted Oct 23, 2025·Initiated Jun 10, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Root cause: Device Design
Recalling firm: SEDECAL SAType: System, X-Ray, MobileDistribution: US: CA, IL, and NJRecall #Z-0242-2026