Open, ClassifiedPosted Oct 10, 2024·Initiated Aug 2, 2024
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R.
Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Reason: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Root cause: Device Design
Recalling firm: AURIS HEALTH INCType: Bronchoscope (Flexible Or Rigid)Distribution: Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.Recall #Z-0051-2025
Open, ClassifiedPosted Oct 10, 2024·Initiated Aug 2, 2024
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Reason: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Root cause: Device Design
Recalling firm: AURIS HEALTH INCType: Ureteroscope And Accessories, Flexible/RigidDistribution: Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.Recall #Z-0052-2025
Open, ClassifiedPosted Oct 10, 2024·Initiated Aug 28, 2024
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Reason: CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.
Root cause: Unknown/Undetermined by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Laparoscopy KitDistribution: US Nationwide distribution in the state of CA.Recall #Z-0053-2025
Open, ClassifiedPosted Oct 10, 2024·Initiated Sep 13, 2024
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
Reason: There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp.Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, WV,
KS, AL, NE, MD, ID, LA, AR, KY, IA, AK, NM, ME, RI and the countries of Madagascar, Malaysia, Guam.Recall #Z-0054-2025
Open, ClassifiedPosted Oct 10, 2024·Initiated Sep 6, 2024
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data .
Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000
(including all SU s and HF s)
Reason: Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.
Root cause: Software design
Recalling firm: Agfa Healthcare NVType: System, Image Processing, RadiologicalDistribution: US Nationwide distribution.
Foreign:
Argentina, Australia, Belgium, Chile, Canada, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Georgia, Greece, Hong Kong, Iceland, Ireland, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, Nicaragua, Norway, Oman, Pakistan, Peru, Poland, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Tanzania, Tunisia, United Arab Emirates, United KingdomRecall #Z-0055-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Sep 13, 2024
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF;
Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Reason: There is a defect in the air-in-line software algorithm.
Root cause: Process change control
Recalling firm: Zyno Medical LLCType: Pump, InfusionDistribution: US Nationwide.Recall #Z-0005-2025
CompletedPosted Oct 9, 2024·Initiated Aug 5, 2024
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
Reason: Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Root cause: Under Investigation by firm
Recalling firm: QUANTUM SURGICAL SASType: System, X-Ray, Tomography, ComputedDistribution: US Nationwide distribution in the state of FL.Recall #Z-0037-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Aug 14, 2024
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Reason: Contamination with foreign substance matter
Root cause: Under Investigation by firm
Recalling firm: 3M Company - Health Care BusinessType: Dressing, Wound, DrugDistribution: International distribution to the country of South Korea.Recall #Z-0038-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Aug 29, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers:
a) 2089507-120;
b) 2089507-129;
c) 2089507-131;
d) 2089507-135;
e) 2089507-136;
f) 2089507-140;
g) 2089507-144;
h) 2089507-145;
i) 2089507-149;
j) 2089507-153;
k) 2089507-154;
l) 2089507-155;
m) 2089507-156;
n) 2089507-157;
o) K2037DAED;
p) K2037DBED;
q) K2037DED;
r) K2037DJED;
s) K2037DNED;
t) K2042TTED;
u) K2049DC;
v) K2049DD;
w) K2049DF;
x) P2037DAED;
y) P2037DBED;
z) P2037DED;
aa) To be provided
Reason: GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
Root cause: Process control
Recalling firm: GE HealthcareType: System, Image Processing, RadiologicalDistribution: Worldwide distribution.Recall #Z-0039-2025 Open, ClassifiedPosted Oct 9, 2024·Initiated Jul 31, 2024
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Reason: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Root cause: Process control
Recalling firm: Inspire Medical Systems Inc.Type: Stimulator, Hypoglossal Nerve, Implanted, ApneaDistribution: Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.Recall #Z-0040-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Jul 31, 2024
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Reason: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Root cause: Process control
Recalling firm: Inspire Medical Systems Inc.Type: Stimulator, Hypoglossal Nerve, Implanted, ApneaDistribution: Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.Recall #Z-0041-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Sep 5, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Reason: Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
Root cause: Device Design
Recalling firm: Luminex Molecular Diagnostics IncType: Respiratory Virus Panel Nucleic Acid Assay SystemDistribution: U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.Recall #Z-0042-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Sep 5, 2024
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Reason: Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
Root cause: Device Design
Recalling firm: Luminex Molecular Diagnostics IncType: Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid DevicesDistribution: U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.Recall #Z-0043-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Aug 7, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Reason: Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Root cause: Vendor change control
Recalling firm: Howmedica Osteonics Corp.Type: Orthopedic Stereotaxic InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Germany.Recall #Z-0044-2025
Open, ClassifiedPosted Oct 9, 2024·Initiated Sep 16, 2024
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Reason: Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Root cause: Process control
Recalling firm: Cook IncorporatedType: Introducer, CatheterDistribution: International distribution to the country of Australia.Recall #Z-0045-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 26, 2024
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Reason: Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
Root cause: Nonconforming Material/Component
Recalling firm: Qualigen IncType: Radioimmunoassay, Thyroid-Stimulating HormoneDistribution: US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV.
OUS: Germany, SwitzerlandRecall #Z-0022-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Sep 12, 2024
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-
IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place.
Catalog Number: 444150
Reason: Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Calculator/Data Processing Module, For Clinical UseDistribution: Nationwide
Foreign:
Australia, New Zealand, Singapore, Hong Kong, Taiwan, Japan, Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Russia, Saudi Arabia, South Africa, Canada, Mexico, ChinaRecall #Z-0026-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 16, 2024
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure.
Reason: Due to convenience kits containing a kit component that is under a recall action for improper use.
Root cause: Use error
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.Recall #Z-0027-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 16, 2024
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure.
Reason: Due to convenience kits containing a kit component that is under a recall action for improper use.
Root cause: Use error
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.Recall #Z-0028-2025
Open, ClassifiedPosted Oct 8, 2024·Initiated Aug 16, 2024
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure.
Reason: Due to convenience kits containing a kit component that is under a recall action for improper use.
Root cause: Use error
Recalling firm: Windstone Medical Packaging, Inc.Type: Ear, Nose, And Throat Surgical TrayDistribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.Recall #Z-0029-2025