Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 3 M12
System Code:
(1) 722063
(2) 722221
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1087-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 3 M15
System Code:
(1) 722064
(2) 722222
(3) 722280
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1088-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 5 M12
System Code:
(1) 722227
(2) 722231
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1089-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 5 M20
System Code:
(1) 722228
(2) 722232
(3) 722281
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1090-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 7 B12
System Code:
(1) 722067
(2) 722225
(3) 722235
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1091-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 7 B20
System Code:
(1) 722068
(2) 722226
(3) 722236
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1092-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 7 M12
System Code:
(1) 722078
(2) 722223
(3) 722233
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1093-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Azurion 7 M20
System code:
(1) 722224
(2) 722079
(3) 722234
(4) 722282
System Code:
(1) 722078
(2) 722223
(3) 722233
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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 Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1094-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 8, 2025
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
Reason: Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.
Root cause: Nonconforming Material/Component
Recalling firm: Hologic, Inc.Type: Device, Specimen CollectionDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Guam and the countries of Canada and Japan.Recall #Z-1095-2025 Open, ClassifiedPosted Feb 4, 2025·Initiated Dec 20, 2024
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
Reason: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Root cause: Process control
Recalling firm: Ethicon, LLCType: Suture, Nonabsorbable, Synthetic, PolypropyleneDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.Recall #Z-1096-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Dec 20, 2024
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
Reason: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Root cause: Process control
Recalling firm: Ethicon, LLCType: Suture, Nonabsorbable, Synthetic, PolypropyleneDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.Recall #Z-1097-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Dec 20, 2024
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H.
Not sold in US
Reason: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Root cause: Process control
Recalling firm: Ethicon, LLCType: Suture, Nonabsorbable, Synthetic, PolypropyleneDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.Recall #Z-1098-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 2, 2025
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion.
Part Number:903-00006
Reason: Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Root cause: Process control
Recalling firm: Belmont Instrument LLCType: Pump, InfusionDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China,
Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.Recall #Z-1099-2025
Open, ClassifiedPosted Feb 3, 2025·Initiated Jan 28, 2025
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Reason: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, StationaryDistribution: Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.Recall #Z-1043-2025
Open, ClassifiedPosted Feb 3, 2025·Initiated Jan 28, 2025
Discovery XR656HD. X-Ray imaging system.
Reason: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, StationaryDistribution: Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.Recall #Z-1044-2025
Open, ClassifiedPosted Feb 3, 2025·Initiated Jan 28, 2025
Discovery XR656 HD. X-Ray imaging system.
Reason: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, StationaryDistribution: Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.Recall #Z-1045-2025
Open, ClassifiedPosted Feb 3, 2025·Initiated Jan 28, 2025
Optima XR646 HD. X-Ray imaging system.
Reason: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, StationaryDistribution: Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.Recall #Z-1046-2025
Open, ClassifiedPosted Jan 31, 2025·Initiated Dec 12, 2024
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System.
Used for Vagus Nerve Stimulation (VNS).
Reason: Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Root cause: Device Design
Recalling firm: LivaNova USA, Inc.Type: Stimulator, Autonomic Nerve, Implanted For EpilepsyDistribution: US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT.
OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.Recall #Z-1072-2025
Open, ClassifiedPosted Jan 31, 2025·Initiated Dec 12, 2024
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation.
Used for Vagus Nerve Stimulation (VNS).
Reason: Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Root cause: Device Design
Recalling firm: LivaNova USA, Inc.Type: Stimulator, Autonomic Nerve, Implanted For EpilepsyDistribution: US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT.
OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.Recall #Z-1073-2025
Open, ClassifiedPosted Jan 30, 2025·Initiated Feb 14, 2023
BD Pyxis MedStation ES AUX Tower REF 343
BD Pyxis " MedStation 4000 AUX Tower REF 314
The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Reason: Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
Root cause: Device Design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Germany and JapanRecall #Z-1050-2025