Open, ClassifiedPosted Aug 14, 2026·Initiated Jun 15, 2026
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Reason: Devices could potentially be occluded or partially occluded.
Root cause: Process control
Recalling firm: Intersurgical IncType: Airway, Oropharyngeal, AnesthesiologyDistribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.Recall #Z-2953-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 20, 2026
Dentsply Sirona Capsule Mixer
Model No. 5546068
Reason: Potential for electrical discharge from unit when unplugged.
Root cause: Device Design
Recalling firm: SDI LimitedType: Amalgamator, Dental, Ac-PoweredDistribution: US: AK AL AR AZ CA CO CT DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV
OUS: NoneRecall #Z-2954-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 1, 2026
Cardiac Workstation 5000. Product Number: 860439.
Reason: Device will intermittently provide inaccurate data related to native heart rate.
Root cause: Software design
Recalling firm: Philips North America LlcType: ElectrocardiographDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.Recall #Z-2955-2026 Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 1, 2026
Cardiac Workstation 7000. Product Number: 860441.
Reason: Device will intermittently provide inaccurate data related to native heart rate.
Root cause: Software design
Recalling firm: Philips North America LlcType: ElectrocardiographDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.Recall #Z-2956-2026 Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 13, 2026
Brand Name: Kico Knee Innovation
Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2
Model/Catalog Number: IN-29200
Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200)
ARVIS Shoulder Software v2.0.3 (IN-23630)
Product Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.
The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to:
" Total Knee Arthroplasty
" Unicompartmental Knee Arthroplasty: Tibial Transverse Resection
" Hip Arthroplasty
The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.
Component: NA
Reason: Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Root cause: Device Design
Recalling firm: Kico Knee Innovation CompanyType: Orthopedic Augmented RealityDistribution: Consignee Consignee Number Region Device Quantity
RFK MEDICAL CE102 RICHMOND VA IN-29200, ARVIS SURGICAL NAVIGATION 1
VALOR MEDICAL CE118 SAN ANTONIO TX IN-29200, ARVIS SURGICAL NAVIGATION 2
JOINT VENTURES MEDICAL CE121 OSHKOSH WI IN-29200, ARVIS SURGICAL NAVIGATION 1
CASTLE MEDICAL CE122 WATERLOO IA IN-29200, ARVIS SURGICAL NAVIGATION 6
GREAT LAKES MEDICAL GL108 NAPERVILLE IL IN-29200, ARVIS SURGICAL NAVIGATION 2
CERTUS MEDICAL GL112 INDIANAPOLIS IN IN-29200, ARVIS SURGICAL NAVIGATION 5
I&S MEDICAL GL113 LOUISVILLE KY IN-29200, ARVIS SURGICAL NAVIGATION 2
PROCORE MEDICAL MA102 PIEDMONT SC IN-29200, ARVIS SURGICAL NAVIGATION 1
FOX MEDTECH MW001 ENGLEWOOD CO IN-29200, ARVIS SURGICAL NAVIGATION 2
MEDSOURCE NE131 TIVERTON RI IN-29200, ARVIS SURGICAL NAVIGATION 4
IMPLANT MEDICAL SALES NE190 HICKSVILLE NY IN-29200, ARVIS SURGICAL NAVIGATION 2
KINETIC MEDICINE NW105 OMAHA NE IN-29200, ARVIS SURGICAL NAVIGATION 4
CALSURG NW115 SANTA BARBARA CA IN-29200, ARVIS SURGICAL NAVIGATION 4
MIDWEST MEDICAL RESOURCES SC181 OVERLAND PARK KS IN-29200, ARVIS SURGICAL NAVIGATION 3
ORTHO & SURGICAL SOLUTIONS SE175 GUAYNABO PR IN-29200, ARVIS SURGICAL NAVIGATION 3
JOINT MEDICAL SOLUTIONS SE180 BIRMINGHAM AL IN-29200, ARVIS SURGICAL NAVIGATION 4
FLT ORTHOPEDICS SE216 TAMPA FL IN-29200, ARVIS SURGICAL NAVIGATION 6
MAC MEDICAL W180 GILBERT AZ IN-29200, ARVIS SURGICAL NAVIGATION 1
CP ORTHO W214 HONOLULU HI IN-29200, ARVIS SURGICAL NAVIGATION 1
UNIFIED ORTHOPEDICS W223 RIVERSIDE CA IN-29200, ARVIS SURGICAL NAVIGATION 18
MOVEMENT MEDICAL W225 SEATTLE WA IN-29200, ARVIS SURGICAL NAVIGATION 6
Total number of devices in the field 78
Open, ClassifiedPosted Aug 14, 2026·Initiated Jun 23, 2026
Arrow-LOK Implant, REF:
21-253519,
21-253522,
21-253525,
21-253528,
21-253530,
21-253533,
21-253535,
21-253540,
21-253545,
21-253550,
21-353513,
21-353516,
27-253519,
27-253522,
27-253525,
27-253528,
27-253530,
27-253533,
27-253535.
Reason: Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Root cause: Process change control
Recalling firm: Arrowhead DE LLCType: Pin, Fixation, SmoothDistribution: US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.Recall #Z-2958-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 8, 2026
TD Navio Midi Speech Generating Device
Model/Catalog Number: 1000798
Reason: Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
Root cause: Device Design
Recalling firm: Tobii Dynavox LlcType: System, Communication, PoweredDistribution: US Nationwide distribution.Recall #Z-2959-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 8, 2026
TD Navio Maxi Speech Generating Device
Model/Catalog Number: 1000799
Reason: Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
Root cause: Device Design
Recalling firm: Tobii Dynavox LlcType: System, Communication, PoweredDistribution: US Nationwide distribution.Recall #Z-2960-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 14, 2026
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Reason: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Endoscopic Tissue Approximation DeviceDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.Recall #Z-2961-2026 Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 14, 2026
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Reason: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Endoscopic Tissue Approximation DeviceDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.Recall #Z-2962-2026 Open, ClassifiedPosted Aug 14, 2026·Initiated Jun 30, 2026
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Reason: Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing.
Root cause: Under Investigation by firm
Recalling firm: Maquet Critical Care ABType: Ventilator, Continuous, Facility UseDistribution: US Nationwide distribution in the states of CA, GA, MN, NY.Recall #Z-2963-2026 Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 10, 2026
Halyard LAVH PACK, Model/Catalog Number: USAR053-11
Reason: A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation.
Root cause: Process control
Recalling firm: AVID Medical, Inc.Type: Obstetrical KitDistribution: US Nationwide distribution in the state of TX.Recall #Z-2964-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 13, 2026
Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF:L2KSY2(D)/10471981
IVD, RxOnly
Reason: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics Products Ltd.Type: Enzyme Linked Immunoabsorption Assay, Treponema PallidumDistribution: Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿Recall #Z-2965-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 13, 2026
Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF(s):L2kSY2/10489085; L2KSY6/10488319
IVD, RxOnly
Reason: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics Products Ltd.Type: Enzyme Linked Immunoabsorption Assay, Treponema PallidumDistribution: Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿Recall #Z-2966-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 20, 2026
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System
REF# PRGNX-8008-001
Reason: Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Root cause: Software design
Recalling firm: Paragonix Technologies Inc.Type: System, Perfusion, KidneyDistribution: US Nationwide distribution in the states and territories of AL, AZ, CA, TN, FL, HI, MN, NJ, TX, UT, CO, CT, DC, MD, GA, KY, LA, MA, MI, MO, MS, NC, ND, NE, NM, NV, NY, PA, PR, SC, UT, VA, WI, WV, IN, OH, KY, IL, MD, MN, OR.Recall #Z-2967-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 13, 2026
Blanketrol II Model 222S; Thermal regulating system.
Reason: Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.
Root cause: Device Design
Recalling firm: Gentherm Medical, LLCType: System, Thermal RegulatingDistribution: Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.Recall #Z-2968-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 13, 2026
Innercool Coolblue Console, Model STx; Thermal regulating system.
Reason: Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.
Root cause: Device Design
Recalling firm: Gentherm Medical, LLCType: System, Thermal RegulatingDistribution: Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.Recall #Z-2969-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 13, 2026
Blanketrol III, Model 233; Thermal regulating system.
Reason: Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down,
Root cause: Device Design
Recalling firm: Gentherm Medical, LLCType: System, Thermal RegulatingDistribution: Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.Recall #Z-2970-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 10, 2026
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Reason: Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Root cause: Under Investigation by firm
Recalling firm: Paragon 28, Inc.Type: Bone WedgeDistribution: US Nationwide distribution i the state of MT.Recall #Z-2971-2026
Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 10, 2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Reason: Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Root cause: Under Investigation by firm
Recalling firm: Paragon 28, Inc.Type: Bone WedgeDistribution: US Nationwide distribution i the state of MT.Recall #Z-2972-2026