Open, ClassifiedPosted Nov 5, 2025·Initiated Sep 30, 2025
Brand Name: Leksell Stereotactic System
Product Name: Leksell Vantage Stereotactic System
Software Version: n/a
Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
Reason: Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
Root cause: Process change control
Recalling firm: Elekta, Inc.Type: Neurological Stereotaxic InstrumentDistribution: Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Kuwait, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.Recall #Z-0433-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 3, 2025
TruDi Navigation System - Multi Instrument Adapter; -
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Reason: It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Root cause: Device Design
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Ear, Nose, And Throat Stereotaxic InstrumentDistribution: US Nationwide distribution.Recall #Z-0420-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Reason: A potential issue with the seal integrity of header bag packaging.
Root cause: Under Investigation by firm
Recalling firm: Mozarc Medical US LLCType: Catheter, Hemodialysis, Triple Lumen, Non-ImplantedDistribution: US Nationwide distribution.Recall #Z-0421-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Reason: A potential issue with the seal integrity of header bag packaging.
Root cause: Under Investigation by firm
Recalling firm: Mozarc Medical US LLCType: Catheter, Hemodialysis, Triple Lumen, Non-ImplantedDistribution: US Nationwide distribution.Recall #Z-0422-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Reason: A potential issue with the seal integrity of header bag packaging.
Root cause: Under Investigation by firm
Recalling firm: Mozarc Medical US LLCType: Catheter, Hemodialysis, Triple Lumen, Non-ImplantedDistribution: US Nationwide distribution.Recall #Z-0423-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Reason: A potential issue with the seal integrity of header bag packaging.
Root cause: Under Investigation by firm
Recalling firm: Mozarc Medical US LLCType: Catheter, Hemodialysis, Triple Lumen, Non-ImplantedDistribution: US Nationwide distribution.Recall #Z-0424-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Reason: A potential issue with the seal integrity of header bag packaging.
Root cause: Under Investigation by firm
Recalling firm: Mozarc Medical US LLCType: Catheter, Hemodialysis, Triple Lumen, Non-ImplantedDistribution: US Nationwide distribution.Recall #Z-0425-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Reason: A potential issue with the seal integrity of header bag packaging.
Root cause: Under Investigation by firm
Recalling firm: Mozarc Medical US LLCType: Catheter, Hemodialysis, Triple Lumen, Non-ImplantedDistribution: US Nationwide distribution.Recall #Z-0426-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 1, 2025
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Reason: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
Root cause: Process control
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: WorldwideRecall #Z-0428-2026
Open, ClassifiedPosted Nov 4, 2025·Initiated Oct 1, 2025
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Reason: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
Root cause: Process control
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: WorldwideRecall #Z-0429-2026
Open, ClassifiedPosted Nov 3, 2025·Initiated Sep 26, 2025
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Reason: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Root cause: Process change control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Drills, Burrs, Trephines & Accessories (Compound, Powered)Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.Recall #Z-0373-2026
Open, ClassifiedPosted Nov 3, 2025·Initiated Sep 26, 2025
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Reason: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Root cause: Process change control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Drills, Burrs, Trephines & Accessories (Compound, Powered)Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.Recall #Z-0374-2026
Open, ClassifiedPosted Nov 3, 2025·Initiated Sep 30, 2025
Brand Name: Inclusive
Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm
Model/Catalog Number: 70-1047-COM0117
Reason: Incorrect titanium screw, packaged with dental implant.
Root cause: Employee error
Recalling firm: Prismatik Dentalcraft, Inc.Type: Abutment, Implant, Dental, EndosseousDistribution: US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.Recall #Z-0417-2026
Open, ClassifiedPosted Nov 3, 2025·Initiated Sep 26, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Reason: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Root cause: Labeling mix-ups
Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedDistribution: US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDSRecall #Z-0418-2026
Open, ClassifiedPosted Nov 3, 2025·Initiated Sep 26, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Reason: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Root cause: Labeling mix-ups
Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedDistribution: US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDSRecall #Z-0419-2026
Open, ClassifiedPosted Oct 31, 2025·Initiated Sep 16, 2025
Brand Name: Sentinel V11
Product Name: Sentinel V11
Model/Catalog Number: 92810
Software Version: 11.6.0
Product Description: Cardiology Information Management System
Component: No
The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.
Reason: Due to two distinct issues:
1. During patient admission, patient demographic fields may default to those of a previously viewed patient.
2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
Root cause: Software design
Recalling firm: Spacelabs Healthcare, Ltd.Type: Computer, Diagnostic, ProgrammableDistribution: Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.Recall #Z-0416-2026
Open, ClassifiedPosted Oct 30, 2025·Initiated Aug 28, 2025
Brand Name: Dexcom G6 Continuous Glucose Monitoring System
Product Name: Dexcom G6 and G6 Pro Android US CGM App
Model/Catalog Number: SW11678
Software Version: version 1.15.0
Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0
Component: Dexcom G6 Continuous Glucose Monitoring System
Reason: A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
Root cause: Software Design Change
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.Recall #Z-0318-2026
Open, ClassifiedPosted Oct 30, 2025·Initiated Sep 8, 2025
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Reason: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
Root cause: Software design
Recalling firm: Beckman Coulter, Inc.Type: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.Recall #Z-0412-2026
Open, ClassifiedPosted Oct 30, 2025·Initiated Oct 7, 2025
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Reason: Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
Root cause: Device Design
Recalling firm: Trividia Health, Inc.Type: System, Test, Blood Glucose, Over The CounterDistribution: US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.Recall #Z-0413-2026 Open, ClassifiedPosted Oct 30, 2025·Initiated Aug 6, 2025
Xpert SA Nasal Complete
Catalog Number: GXSACOMP-10
UDI-DI code: 07332940000158
Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
Reason: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Root cause: Under Investigation by firm
Recalling firm: CepheidType: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenDistribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY.Recall #Z-0414-2026