Open, ClassifiedPosted Nov 21, 2024·Initiated Oct 14, 2024
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Reason: Devices from the affected device lots have labels that state the incorrect expiration dates.
Root cause: Labeling Change Control
Recalling firm: Cook IncorporatedType: Wire, Guide, CatheterDistribution: International Distribution to: Korea onlyRecall #Z-0499-2025
Open, ClassifiedPosted Nov 21, 2024·Initiated Sep 30, 2024
Precice Max REF:
PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm
PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm
PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm
PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm
PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm
PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 265mm
PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 280mm
PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 305mm
PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm
PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm
PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm
PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm
PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm
PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 265mm
PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 280mm
PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 305mm
PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm
PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm
PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm
The Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus.
Reason: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Root cause: Under Investigation by firm
Recalling firm: NuVasive Specialized Orthopedics, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: U.S distribution to states of: FL and NV.Recall #Z-0500-2025
Open, ClassifiedPosted Nov 21, 2024·Initiated Oct 15, 2024
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers.
Model/Catalog Number: D0003
The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
Reason: Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Root cause: Device Design
Recalling firm: OrganOx LtdType: Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To TransplantationDistribution: California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.Recall #Z-0501-2025
Open, ClassifiedPosted Nov 21, 2024·Initiated Oct 18, 2024
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF.
The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
Reason: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Root cause: Device Design
Recalling firm: Zyno Medical LLCType: Pump, InfusionDistribution: This product is distributed only in the United States.Recall #Z-0506-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0373-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0374-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0375-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0376-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0377-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0378-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0379-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0380-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0381-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Reason: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like
(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
peritoneal dialysis and hemodialysis devices.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide Distribution (US Nationwide distribution)Recall #Z-0382-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 17, 2024
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Root cause: Under Investigation by firm
Recalling firm: Abbott MedicalType: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.Recall #Z-0491-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 17, 2024
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Root cause: Under Investigation by firm
Recalling firm: Abbott MedicalType: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.Recall #Z-0492-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 17, 2024
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Root cause: Under Investigation by firm
Recalling firm: Abbott MedicalType: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.Recall #Z-0493-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 17, 2024
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Root cause: Under Investigation by firm
Recalling firm: Abbott MedicalType: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.Recall #Z-0494-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 17, 2024
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Root cause: Under Investigation by firm
Recalling firm: Abbott MedicalType: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.Recall #Z-0495-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 21, 2024
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step.
Siemens Material Number(SMN): 11099326
All lots starting with N15 or 15 are expected to have the defect.
Reason: A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for
seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine
Kinase (CK), Cystatin C, and Salicylate.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: US Nationwide and Worldwide distribution:
Foreign:
Algeria
Algeria
Argentina
Australia
Austria
Bahrain
Bangladesh
Belgium
Brazil
Bulgaria
Burkina Faso
Canada
Chile
China
Colombia
Congo, Republic
C¿te dIvoire
Croatia
Cyprus
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Iran, Islamic Republic of
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kenya
Kuwait
Latvia
Libya
Malaysia
Mexico
Moldova, Rep. of
Morocco
Nepal
Netherlands
Norway
Oman
Pakistan
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
Republic Korea
Romania
Russian Federation
Saudi Arabia
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan, Province of China
Thailand
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
Vatikancity
VietnamRecall #Z-0496-2025