Open, ClassifiedPosted Jan 28, 2025·Initiated Nov 18, 2024
Medline procedure kits labeled as:
1) Port Access Kit, Reorder number CVI5130;
2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Reason: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution.Recall #Z-1040-2025
Open, ClassifiedPosted Jan 28, 2025·Initiated Nov 18, 2024
Medline procedure kits labeled as:
1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Reason: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tray, SurgicalDistribution: US Nationwide distribution.Recall #Z-1041-2025
Open, ClassifiedPosted Jan 28, 2025·Initiated Nov 18, 2024
Medline procedure kits labeled as:
1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Reason: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Dressing Change TrayDistribution: US Nationwide distribution.Recall #Z-1042-2025
Open, ClassifiedPosted Jan 27, 2025·Initiated Dec 4, 2024
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235
Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236
The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
Reason: Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Navigation, Inc.Type: Orthopedic Stereotaxic InstrumentDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, 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. The countries of Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Czech Republic, Denmark, Finland, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Arab Emirates, United Kingdom, Vietnam.Recall #Z-1022-2025
CompletedPosted Jan 27, 2025·Initiated Dec 23, 2024
CyberKnife Treatment Delivery System, REF 0660000
The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason: Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
Root cause: Component design/selection
Recalling firm: Accuray IncorporatedType: Accelerator, Linear, MedicalDistribution: Worldwide - US Nationwide distribution.Recall #Z-1023-2025 Open, ClassifiedPosted Jan 24, 2025·Initiated Dec 18, 2024
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Reason: Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
Root cause: Under Investigation by firm
Recalling firm: Instrumentation LaboratoryType: Assay, HeparinDistribution: Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Korea (the Republic of), Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Mexico, Netherlands (the), Norway, Philippines (the), Poland, Portugal, Qatar, Romania, Russian Federation (the), Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan (Province of China), Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Viet Nam.Recall #Z-1020-2025 Open, ClassifiedPosted Jan 24, 2025·Initiated Dec 4, 2024
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control.
Model/Catalog Number: 530159
Reason: Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Root cause: Nonconforming Material/Component
Recalling firm: B. Braun Medical, Inc.Type: Spinal Epidural Anesthesia KitDistribution: US Nationwide distribution in the states of MO, OK.Recall #Z-1021-2025 Open, ClassifiedPosted Jan 23, 2025·Initiated Dec 23, 2024
VDR4 Phasitron Breathing Circuit Models that contain the venturi component:
-A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk
-A51001, VDR4 Control Unit Tester
-PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON
-PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10
-PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10
The Phasitron breathing circuit kit is intended to be used for
continuous ventilation intended for controlled ventilation of patients
Reason: Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
Root cause: Process control
Recalling firm: Percussionaire CorporationType: Ventilator, Continuous, Facility UseDistribution: Worldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO, NE, NJ, NY, NC, RI, TX, UT, and WV. The countries of Belgium, Canada, France, Hong Kong, Netherlands, Russia, Switzerland and Turkey.Recall #Z-0960-2025
Open, ClassifiedPosted Jan 23, 2025·Initiated Dec 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP3403
Reason: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Root cause: No Marketing Application
Recalling firm: Randox Laboratories, LimitedType: Lipoprotein, Low-Density, Antigen, Antiserum, ControlDistribution: US Nationwide distribution Including PR.Recall #Z-1017-2025 Open, ClassifiedPosted Jan 23, 2025·Initiated Dec 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP2757
Reason: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Root cause: No Marketing Application
Recalling firm: Randox Laboratories, LimitedType: Lipoprotein, Low-Density, Antigen, Antiserum, ControlDistribution: US Nationwide distribution Including PR.Recall #Z-1018-2025 Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 20, 2024
Brand Name: N/A
Product Name: Repeater Bone Tamp
Model/Catalog Number: ASY-00132
Software Version: N/A
Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures.
Component: No
Reason: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Root cause: Device Design
Recalling firm: Integrity Implants Inc.Type: Orthopedic Manual Surgical InstrumentDistribution: U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.Recall #Z-1008-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 20, 2024
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Reason: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, IntravascularDistribution: US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.Recall #Z-1009-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 20, 2024
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Reason: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, IntravascularDistribution: US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.Recall #Z-1010-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 20, 2024
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Reason: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, IntravascularDistribution: US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.Recall #Z-1011-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 13, 2024
Brand Name: IMed Products
Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD
Model/Catalog Number: IM46062
Software Version: N/A
Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected.
Component: No
Reason: Potential for hole in package compromising sterility of the medical kit.
Root cause: Process control
Recalling firm: Trinity Sterile, Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, PA, TN and TX.Recall #Z-1012-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 13, 2024
Brand Name: Wolf-Pak
Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30
Model/Catalog Number: DC3077LF
Software Version: N/A
Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected.
Component: No
Reason: Potential for hole in package compromising sterility of the medical kit.
Root cause: Process control
Recalling firm: Trinity Sterile, Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, PA, TN and TX.Recall #Z-1013-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 13, 2024
Brand Name: Wolf-Pak
Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30
Model/Catalog Number: DC3080LF
Software Version: N/A
Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected.
Component: No
Reason: Potential for hole in package compromising sterility of the medical kit.
Root cause: Process control
Recalling firm: Trinity Sterile, Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, PA, TN and TX.Recall #Z-1014-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 13, 2024
Brand Name: Wolf-Pak
Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30
Model/Catalog Number: DC5090LF
Software Version: N/A
Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected.
Component: No
Reason: Potential for hole in package compromising sterility of the medical kit.
Root cause: Process control
Recalling firm: Trinity Sterile, Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, PA, TN and TX.Recall #Z-1015-2025
Open, ClassifiedPosted Jan 22, 2025·Initiated Dec 13, 2024
Brand Name: Tacy Medical, Inc.
Product Name: Dressing Change Tray CS/20
Model/Catalog Number: TM6180CP
Software Version: N/A
Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected.
Component: No
Reason: Potential for hole in package compromising sterility of the medical kit.
Root cause: Process control
Recalling firm: Trinity Sterile, Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, PA, TN and TX.Recall #Z-1016-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: R5000687
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-0993-2025