Open, ClassifiedPosted Nov 27, 2024·Initiated Oct 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
Reason: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Root cause: Under Investigation by firm
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide distribution.Recall #Z-0568-2025
Open, ClassifiedPosted Nov 27, 2024·Initiated Oct 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Reason: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Root cause: Under Investigation by firm
Recalling firm: Baxter Healthcare CorporationType: Set, Administration, For Peritoneal Dialysis, DisposableDistribution: Worldwide distribution.Recall #Z-0569-2025
Open, ClassifiedPosted Nov 27, 2024·Initiated Nov 1, 2024
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
Reason: Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
Root cause: Software Design Change
Recalling firm: Securitas Healthcare LLCType: System, Environmental Control, PoweredDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.Recall #Z-0570-2025
Open, ClassifiedPosted Nov 27, 2024·Initiated Oct 18, 2024
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Reason: Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
Root cause: Software change control
Recalling firm: LivaNova Deutschland GmbHType: Console, Heart-Lung Machine, Cardiopulmonary BypassDistribution: US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.Recall #Z-0571-2025
Open, ClassifiedPosted Nov 27, 2024·Initiated Nov 11, 2024
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Reason: An out of specification component may result in the device exhibiting torque output higher than the design specification.
Root cause: Process change control
Recalling firm: Gauthier Biomedical, Inc.Type: Orthopedic Manual Surgical InstrumentDistribution: US Nationwide distribution in the state of MA.Recall #Z-0572-2025
Open, ClassifiedPosted Nov 27, 2024·Initiated Oct 22, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason: Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
Root cause: Environmental control
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US: TX, PR, MD, CARecall #Z-0580-2025
Open, ClassifiedPosted Nov 26, 2024·Initiated Oct 10, 2024
BioZorb Marker. Radiographic soft tissue marker.
Reason: Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Root cause: Device Design
Recalling firm: Hologic, IncType: Marker, Radiographic, ImplantableDistribution: Domestic: US Nationwide Distribution.Recall #Z-0328-2025 Open, ClassifiedPosted Nov 26, 2024·Initiated Oct 1, 2024
Merlin@home Transmitter REF EX1100
The Merlin@home" (M@h) transmitter is intended to transfer stored data from
the patient s implanted heart device to Merlin.net" Patient Care Network (PCN)
to facilitate remote monitoring by using inductive (EX1100 Model) or RF
telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net
PCN server.
Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Root cause: Software design
Recalling firm: Abbott MedicalType: Pulse Generator, Permanent, ImplantableDistribution: Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.Recall #Z-0551-2025
Open, ClassifiedPosted Nov 26, 2024·Initiated Oct 1, 2024
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150
Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter
configured for multiple patient use. It can receive information from an
implantable heart device in unpaired mode. With MoD capability, the transmitter
will retrieve full follow-up data or retrieve data for display on the Merlin.net"
Patient Care Network (PCN). The MoD capability enables clinicians to do the
following:
. support remote care patients in emergency rooms and heart failure clinics
. triage patients for in clinic follow-ups
. support patients in a clinical setting with Merlin.net PCN
Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Root cause: Software design
Recalling firm: Abbott MedicalType: Pulse Generator, Permanent, ImplantableDistribution: Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.Recall #Z-0552-2025
Open, ClassifiedPosted Nov 26, 2024·Initiated Oct 9, 2024
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
Reason: There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
Root cause: Device Design
Recalling firm: Shimadzu Corp. Analytical & Measuring Instruments Div.Type: Apparatus, High Pressure Liquid ChromatographyDistribution: Worldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.Recall #Z-0553-2025
Open, ClassifiedPosted Nov 26, 2024·Initiated Oct 9, 2024
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Reason: There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.
Root cause: Device Design
Recalling firm: Shimadzu Corp. Analytical & Measuring Instruments Div.Type: Apparatus, High Pressure Liquid ChromatographyDistribution: Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.Recall #Z-0554-2025
Open, ClassifiedPosted Nov 26, 2024·Initiated Oct 28, 2024
Tempus LS-Manual Defibrillator Model 00-3020
The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Reason: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Root cause: Labeling Change Control
Recalling firm: Remote Diagnostic Technologies Ltd.Type: Dc-Defibrillator, Low-Energy, (Including Paddles)Distribution: U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.Recall #Z-0557-2025
Open, ClassifiedPosted Nov 26, 2024·Initiated Oct 25, 2024
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case;
Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Reason: Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
Root cause: Labeling Change Control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Laparoscopy KitDistribution: US Nationwide distribution in the state of NY.Recall #Z-0558-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 14, 2024
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline
Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
Reason: Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.
Root cause: Under Investigation by firm
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: IrelandRecall #Z-0502-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 14, 2024
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and
Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
Reason: Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized
label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor
electrical connection to the patient, which can reduce the energy delivered to the patient
Root cause: Under Investigation by firm
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: IrelandRecall #Z-0503-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 14, 2024
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
Reason: Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized
label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor
electrical connection to the patient, which can reduce the energy delivered to the patient
Root cause: Under Investigation by firm
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: IrelandRecall #Z-0504-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 14, 2024
Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series
-Indicated for use on victims of sudden cardiac arrest (SCA.)
Reason: Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor
electrical connection to the patient, which can reduce the energy delivered to the patient
Root cause: Under Investigation by firm
Recalling firm: Defibtech, LLCType: Automated External Defibrillators (Non-Wearable)Distribution: IrelandRecall #Z-0505-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 11, 2024
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x
3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x
5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x
5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x
6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x
4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x
5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x
5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x
Reason: Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
Root cause: Under Investigation by firm
Recalling firm: Karl Storz EndoscopyType: ArthroscopeDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.Recall #Z-0526-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 28, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Reason: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Root cause: Under Investigation by firm
Recalling firm: Smiths Medical ASD, Inc.Type: Stylet, Tracheal TubeDistribution: Worldwide distribution.Recall #Z-0527-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 28, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Reason: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Root cause: Under Investigation by firm
Recalling firm: Smiths Medical ASD, Inc.Type: Stylet, Tracheal TubeDistribution: Worldwide distribution.Recall #Z-0528-2025