Open, ClassifiedPosted Feb 20, 2025·Initiated Dec 16, 2024
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Reason: There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It
turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.Recall #Z-1198-2025
Open, ClassifiedPosted Feb 20, 2025·Initiated Dec 16, 2024
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Reason: There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It
turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.Recall #Z-1199-2025
Open, ClassifiedPosted Feb 20, 2025·Initiated Feb 13, 2025
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Reason: Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Culture Media, Selective And DifferentialDistribution: US Nationwide distribution.Recall #Z-1200-2025
Open, ClassifiedPosted Feb 20, 2025·Initiated Feb 13, 2025
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Reason: Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Culture Media, Selective And DifferentialDistribution: US Nationwide distribution.Recall #Z-1201-2025
Open, ClassifiedPosted Feb 20, 2025·Initiated Jan 27, 2025
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Reason: Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose
alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net
error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a
subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one.
Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the
receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event.
Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the
user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.Recall #Z-1202-2025
Open, ClassifiedPosted Feb 20, 2025·Initiated Jan 27, 2025
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Reason: Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose
alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net
error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a
subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one.
Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the
receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event.
Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the
user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.Recall #Z-1203-2025
Open, ClassifiedPosted Feb 20, 2025·Initiated Jan 27, 2025
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
Reason: Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose
alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net
error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a
subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one.
Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the
receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event.
Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the
user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.Recall #Z-1204-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 3, 2025
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE))
Reason: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Root cause: Labeling Change Control
Recalling firm: XTANT Medical Holdings, IncType: Intervertebral Fusion Device With Integrated Fixation, LumbarDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.Recall #Z-1177-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Dec 23, 2024
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Reason: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Root cause: Process change control
Recalling firm: Hollister IncorporatedType: Device, Fixation, Tracheal TubeDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1178-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Dec 23, 2024
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Reason: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Root cause: Process change control
Recalling firm: Hollister IncorporatedType: Device, Fixation, Tracheal TubeDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1179-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Dec 23, 2024
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Reason: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Root cause: Process change control
Recalling firm: Hollister IncorporatedType: Device, Fixation, Tracheal TubeDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1180-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Dec 23, 2024
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Reason: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Root cause: Process change control
Recalling firm: Hollister IncorporatedType: Device, Fixation, Tracheal TubeDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1181-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 9, 2025
Medline Convenience Kits for Various Procedures:
1) ADULT INTUBATION TRAY, Model Number DYNJAA254A;
2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
Reason: Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: US States: CA, NYRecall #Z-1182-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 9, 2025
Medline Convenience Kits for Various Procedures:
1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809;
2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Reason: Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US States: CA, NYRecall #Z-1183-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 21, 2025
LIFEPAK 15 V4/Masimo Rainbow Sensors:
Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515
Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sensor REF 11996-000519
Masimo LNCS-II rainbow DCI 8 SpCO, Pediatric Reusable Sensor REF 11996-000520
The LIFEPAK 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols.
RD rainbow" 8 SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2),
pulse rate, carboxyhemoglobin saturation (SpCO), and methemoglobin saturation (SpMet) for use with adult, pediatric, infant, and neonatal patients
during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home
environments.
Reason: Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Root cause: Device Design
Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MS, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WV.Recall #Z-1184-2025 Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System.
Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10
Software Version: RayStation 7, 8A and 8A Service Pack 1
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1185-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142
Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1186-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10
Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1187-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 10.1.0.613 and 10.1.1.54
Software Version: RayStation 10B and 10B Service Pack 1
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1188-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15
Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1189-2025