Open, ClassifiedPosted Jan 9, 2026·Initiated Oct 29, 2025
Medicrea, IB3D Universal Implant Inserter, Rx Only
REF: A24000000
Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Root cause: Under Investigation by firm
Recalling firm: Medicrea InternationalType: Intervertebral Fusion Device With Bone Graft, LumbarDistribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.Recall #Z-1038-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Oct 29, 2025
Medicrea, IB3D PL Instruments Set, Rx Only
REF: SPS03174
Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Root cause: Under Investigation by firm
Recalling firm: Medicrea InternationalType: Intervertebral Fusion Device With Bone Graft, LumbarDistribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.Recall #Z-1039-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 4, 2025
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Root cause: Labeling Change Control
Recalling firm: Mobius Imaging, LLCType: System, X-Ray, Tomography, ComputedDistribution: US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.Recall #Z-1040-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 4, 2025
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Root cause: Labeling Change Control
Recalling firm: Mobius Imaging, LLCType: System, X-Ray, Tomography, ComputedDistribution: US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.Recall #Z-1041-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 3, 2025
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,
1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;
2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;
Catheter, Angioplasty, Peripheral, Transluminal
Reason: Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
Root cause: Process change control
Recalling firm: Boston Scientific CorporationType: Catheter, Angioplasty, Peripheral, TransluminalDistribution: US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.Recall #Z-1042-2026 Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 3, 2025
A71200 Vanta" Clinician Programmer Application (CP App) version
2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Reason: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Root cause: Software design
Recalling firm: Medtronic NeuromodulationType: Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefDistribution: Worldwide - US Nationwide distribution.Recall #Z-1043-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 10, 2025
SMV DSX New Line,
System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and
listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
There have been no reports of detector falls or injuries as a result of this potential issue.
The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: Camera, Scintillation (Gamma)Distribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, GreeceRecall #Z-1044-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 10, 2025
SMV DSI,
System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and
listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
There have been no reports of detector falls or injuries as a result of this potential issue.
The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, GreeceRecall #Z-1045-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 10, 2025
SMV BodyTrack,
System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and
listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
There have been no reports of detector falls or injuries as a result of this potential issue.
The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: Camera, Scintillation (Gamma)Distribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, GreeceRecall #Z-1046-2026
Open, ClassifiedPosted Jan 9, 2026·Initiated Dec 10, 2025
MAXXUS,
System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and
listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
There have been no reports of detector falls or injuries as a result of this potential issue.
The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, GreeceRecall #Z-1047-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 5, 2025
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Reason: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max
systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When
switching quickly between organ programs (OGPs) the collimation may be incorrect.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. and OUSRecall #Z-0999-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 3, 2025
Philips Incisive CT
Reason: Potential for incomplete scan due to unstable connection inside of floating sensor.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Philips Healthcare (Suzhou) Co., Ltd.Type: System, X-Ray, Tomography, ComputedDistribution: U.S. and U.S. territoriesRecall #Z-1003-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Nov 26, 2025
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R.
USB 2-Channel IBP Module, REF: 01-2017.
Used with User/Operator Manual
Reason: Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
Root cause: Device Design
Recalling firm: Remote Diagnostic Technologies Ltd.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, GI, ZA, AF, SE, FI.Recall #Z-1027-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 3, 2025
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03
137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01
139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03
139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01
Software Versions:
System Versions 1.6.1 - 1.11.0
Server Application Versions ES 5.4X - 5.8.X
The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
Reason: Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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 Bermuda, and Canada.Recall #Z-1028-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Nov 17, 2025
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason: Customer complaints of Pressio monitor rebooting.
Root cause: Software design
Recalling firm: SophysaType: Device, Monitoring, Intracranial PressureDistribution: US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.Recall #Z-1029-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 4, 2025
Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
Reason: Device packaged in incorrect outer box carton.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: International distribution to the country of Australia and Taiwan.Recall #Z-1030-2026 Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 8, 2025
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Reason: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Root cause: Under Investigation by firm
Recalling firm: Securitas Healthcare LLCType: System, Environmental Control, PoweredDistribution: Worldwide distribution -US Nationwide and the country of Canada.Recall #Z-1031-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 8, 2025
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Reason: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Root cause: Under Investigation by firm
Recalling firm: Securitas Healthcare LLCType: System, Environmental Control, PoweredDistribution: Worldwide distribution -US Nationwide and the country of Canada.Recall #Z-1032-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 12, 2025
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Reason: It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Root cause: Software design
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US Nationwide distribution.Recall #Z-1033-2026 Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 8, 2025
Brand Name: HFD100
Product Name: Head Fixation Device HFD100
Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600
Software Version: Not Applicable
Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while
introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore.
Component: Not a component.
Reason: Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
Root cause: Device Design
Recalling firm: IMRIS Imaging IncType: Holder, Head, Neurosurgical (Skull Clamp)Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.Recall #Z-1034-2026