Open, ClassifiedPosted Feb 12, 2026·Initiated Jan 20, 2023
Surepulse VS Cap Medium
REF: SP-161-A1
component of VS Newborn Heart Rate Monitor
Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Root cause: Labeling Change Control
Recalling firm: SUREPULSE MEDICAL LTDType: OximeterDistribution: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.Recall #Z-1358-2026
Open, ClassifiedPosted Feb 12, 2026·Initiated Jan 20, 2023
Surepulse VS Cap Large
REF: SP-162-A1
component of VS Newborn Heart Rate Monitor
Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Root cause: Labeling Change Control
Recalling firm: SUREPULSE MEDICAL LTDType: OximeterDistribution: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.Recall #Z-1359-2026
Open, ClassifiedPosted Feb 12, 2026·Initiated Jan 20, 2023
Surepulse VS Cap Extra Large
REF: SP-163-A1
component of VS Newborn Heart Rate Monitor
Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Root cause: Labeling Change Control
Recalling firm: SUREPULSE MEDICAL LTDType: OximeterDistribution: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.Recall #Z-1360-2026
Open, ClassifiedPosted Feb 12, 2026·Initiated May 23, 2025
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Reason: This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Root cause: Process control
Recalling firm: Steris CorporationType: Camera, Surgical And AccessoriesDistribution: US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.Recall #Z-1361-2026 Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 13, 2026
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA)
1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052;
2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062;
3) LCSU 4, RTCA; Catalog Number: 881152;
Reason: units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
Root cause: Nonconforming Material/Component
Recalling firm: Laerdal Medical CorporationType: Apparatus, Suction, Ward Use, Portable, Ac-PoweredDistribution: Worldwide distribution - US Nationwide and the countries of Denmark, Sweden, Norway, Canada, Finland, Australia, Spain, France, United Kingdom, Italy, Korea, Germany, Netherlands, Switzerland, New Zealand, Singapore, Malaysia, Austria.Recall #Z-1341-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 2, 2026
ATEC Lateral Navigation Disc Prep Instruments
LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N
UDI-DI code: 00190376476179; GMDN 12844
The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Reason: Due a design issue where the navigated array connection geometry is incorrect.
Root cause: Device Design
Recalling firm: Alphatec Spine, Inc.Type: Orthopedic Stereotaxic InstrumentDistribution: U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.Recall #Z-1342-2026 Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 2, 2026
ATEC Lateral Navigation Disc Prep Instruments
LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N
UDI-DI code: 00190376541471; GMDN 12844
The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Reason: Due a design issue where the navigated array connection geometry is incorrect.
Root cause: Device Design
Recalling firm: Alphatec Spine, Inc.Type: Orthopedic Stereotaxic InstrumentDistribution: U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.Recall #Z-1343-2026 Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 3 M12
System Model Numbers: (1) 722063, (2) 722221, (3) 722229;
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1344-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 3 M15
System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1345-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 7 B12
System Model Numbers:(1) 722067, (2) 722225, (3) 722235;
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1346-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 7 B20
System Model Numbers: (1)722068, (2)722226, (3)722236;
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1347-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 7 M12
System Model Numbers: (1)722078, (2)722223, (3)722233;
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1348-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 7 M20
System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1349-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 5 M12
System Model Numbers: (1)722227, (2)722231;
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1350-2026
Open, ClassifiedPosted Feb 11, 2026·Initiated Jan 26, 2026
Azurion 5 M20
System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.Recall #Z-1351-2026
Open, ClassifiedPosted Feb 10, 2026·Initiated Dec 12, 2025
Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Version: 11.1
Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Reason: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Root cause: Use error
Recalling firm: Elekta, Inc.Type: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.Recall #Z-1339-2026
Open, ClassifiedPosted Feb 10, 2026·Initiated Dec 12, 2025
Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Version: 11,3, 11.4
Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Reason: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Root cause: Use error
Recalling firm: Elekta, Inc.Type: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.Recall #Z-1340-2026
Open, ClassifiedPosted Feb 9, 2026·Initiated Dec 24, 2025
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Root cause: Packaging change control
Recalling firm: Medline Industries, LPType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: US Nationwide distribution.Recall #Z-1326-2026
Open, ClassifiedPosted Feb 9, 2026·Initiated Dec 24, 2025
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Root cause: Packaging change control
Recalling firm: Medline Industries, LPType: Cardiac Catheterization KitDistribution: US Nationwide distribution.Recall #Z-1327-2026
Open, ClassifiedPosted Feb 9, 2026·Initiated Dec 24, 2025
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Root cause: Packaging change control
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide distribution.Recall #Z-1328-2026