FDA Medical Device Recalls

Open, ClassifiedPosted Dec 3, 2024·Initiated Oct 31, 2024

BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570

Reason: BD confirmed that 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 and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.Recall #Z-0595-2025

Open, ClassifiedPosted Dec 3, 2024·Initiated Oct 31, 2024

BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475

Reason: BD confirmed that 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 and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.

Open, ClassifiedPosted Dec 2, 2024·Initiated Aug 8, 2024

Ziehm Solo. Digital Mobile C-arm

Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Orthoscan, Inc.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. (including Puerto Rico).Recall #Z-0573-2025

Open, ClassifiedPosted Dec 2, 2024·Initiated Aug 8, 2024

Ziehm Solo FD. Interventional fluoroscopic x-ray system

Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Orthoscan, Inc.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. (including Puerto Rico).Recall #Z-0574-2025

Open, ClassifiedPosted Dec 2, 2024·Initiated Aug 8, 2024

Ziehm Vision system, x-ray, tomography, computed.

Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Orthoscan, Inc.Type: System, X-Ray, Tomography, ComputedDistribution: U.S. (including Puerto Rico).Recall #Z-0575-2025

Open, ClassifiedPosted Dec 2, 2024·Initiated Aug 8, 2024

Ziehm Vision FD. Interventional fluoroscopic x-ray system

Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Orthoscan, Inc.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. (including Puerto Rico).Recall #Z-0576-2025

Open, ClassifiedPosted Dec 2, 2024·Initiated Aug 8, 2024

Ziehm Vision R. Iterventional fluoroscopic x-ray system

Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Orthoscan, Inc.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. (including Puerto Rico).Recall #Z-0577-2025

Open, ClassifiedPosted Dec 2, 2024·Initiated Aug 8, 2024

Ziehm Vision RFD. Interventional fluoroscopic x-ray system

Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Orthoscan, Inc.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. (including Puerto Rico).Recall #Z-0578-2025

Open, ClassifiedPosted Dec 2, 2024·Initiated Aug 8, 2024

Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system

Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Orthoscan, Inc.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. (including Puerto Rico).Recall #Z-0579-2025

Open, ClassifiedPosted Dec 2, 2024·Initiated Oct 31, 2024

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

Reason: Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.

Root cause: Nonconforming Material/Component

Recalling firm: Wilson-Cook Medical Inc.Type: Hemostatic Device For Endoscopic Gastrointestinal UseDistribution: Distribution was OUS only to Argentina, Brazil, and Israel.Recall #Z-0582-2025

Open, ClassifiedPosted Nov 29, 2024·Initiated Oct 29, 2024

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Reason: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Root cause: Package design/selection

Recalling firm: Smith & Nephew Inc.Type: Fastener, Fixation, Nondegradable, Soft TissueDistribution: Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.Recall #Z-0581-2025