Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0968-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0969-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0970-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Feb 14, 2023
BD Pyxis MedStation ES (Med ES Main), REF 323
Reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified:
Situation 1: Door Latch Failure,
Situation 2: Cable Ribbon Damage,
Situation 3: Magnet Falling Out,
Root cause: Nonconforming Material/Component
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: WorldwideRecall #Z-0971-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Feb 14, 2023
BD Pyxis MedStation ES AUX, REF 324
Reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified:
Situation 1: Door Latch Failure,
Situation 2: Cable Ribbon Damage,
Situation 3: Magnet Falling Out,
Root cause: Nonconforming Material/Component
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: WorldwideRecall #Z-0972-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Feb 14, 2023
BD Pyxis MedStation 4000 Main, REF 303
Reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified:
Situation 1: Door Latch Failure,
Situation 2: Cable Ribbon Damage,
Situation 3: Magnet Falling Out,
Root cause: Nonconforming Material/Component
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: WorldwideRecall #Z-0973-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Feb 14, 2023
BD Pyxis MedStation 4000 AUX, REF 306
Reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified:
Situation 1: Door Latch Failure,
Situation 2: Cable Ribbon Damage,
Situation 3: Magnet Falling Out,
Root cause: Nonconforming Material/Component
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: WorldwideRecall #Z-0974-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Feb 14, 2023
BD Pyxis Med ES Auxiliary (AUX), REF 343
Reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified:
Situation 1: Door Latch Failure,
Situation 2: Cable Ribbon Damage,
Situation 3: Magnet Falling Out,
Root cause: Nonconforming Material/Component
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: WorldwideRecall #Z-0975-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Feb 14, 2023
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified:
Situation 1: Door Latch Failure,
Situation 2: Cable Ribbon Damage,
Situation 3: Magnet Falling Out,
Root cause: Nonconforming Material/Component
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: WorldwideRecall #Z-0976-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Dec 16, 2024
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810
Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Root cause: Labeling Change Control
Recalling firm: Integra LifeSciences Corp.Type: Shunt, Central Nervous System And ComponentsDistribution: US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.Recall #Z-0977-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Dec 16, 2024
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL.
Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Root cause: Labeling Change Control
Recalling firm: Integra LifeSciences Corp.Type: Shunt, Central Nervous System And ComponentsDistribution: US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.Recall #Z-0978-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Dec 16, 2024
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820.
Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Root cause: Labeling Change Control
Recalling firm: Integra LifeSciences Corp.Type: Shunt, Central Nervous System And ComponentsDistribution: US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.Recall #Z-0979-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Jun 28, 2023
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries.
The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries.
These burs are sold as single use devices without their own IFU.
Reason: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
Root cause: Process control
Recalling firm: Stryker CorporationType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.Recall #Z-0980-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Jun 28, 2023
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Reason: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
Root cause: Process control
Recalling firm: Stryker CorporationType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.Recall #Z-0981-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Jun 28, 2023
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Reason: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
Root cause: Process control
Recalling firm: Stryker CorporationType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.Recall #Z-0982-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 26, 2024
Brand Name: HALYARD
Product Name: Laparotomy Pack
Model/Catalog Number: 88231
Software Version: N/A
Product Description: Laparotomy Pack
Component: N/A
Reason: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Root cause: Process control
Recalling firm: O&M HALYARD, INC.Type: Drape, Surgical, AntimicrobialDistribution: US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.Recall #Z-0983-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Dec 12, 2024
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Reason: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Root cause: Packaging
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-0984-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Dec 12, 2024
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Reason: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Root cause: Packaging
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-0985-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Dec 12, 2024
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Reason: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Root cause: Packaging
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-0986-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 6, 2024
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000)
(Which interfaces with CardioMEMS" Hospital System model CM3100)
The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
Reason: Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
Root cause: Under Investigation by firm
Recalling firm: St. Jude MedicalType: System, Hemodynamic, ImplantableDistribution: U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA.
O.U.S.: N/ARecall #Z-0987-2025