Open, ClassifiedPosted Sep 8, 2025·Initiated Jul 31, 2025
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Reason: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Root cause: Under Investigation by firm
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.Recall #Z-2541-2025
Open, ClassifiedPosted Sep 8, 2025·Initiated Aug 11, 2025
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Reason: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Biuret (Colorimetric), Total ProteinDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan,
U.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.Recall #Z-2542-2025 Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 6, 2025
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019.
The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Reason: Potential for undetected, deformed a-traumatic tips.
Root cause: Process design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope AccessoryDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.Recall #Z-2484-2025
Open, ClassifiedPosted Sep 5, 2025·Initiated Jul 21, 2025
Brand Name: CELSITE
Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA
Model/Catalog Number: 5433742
Software Version: N/A
Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA
Component: N/A
Reason: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Root cause: Under Investigation by firm
Recalling firm: B.Braun Medical S.A.S.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: US Nationwide distribution in the state of PA.Recall #Z-2528-2025
Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 12, 2025
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Reason: Limited system movements after startup .
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.Recall #Z-2529-2025
Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 4, 2025
Halyard, ENT PACK. Model Number: JACK421-04.
Convenience kit.
Reason: Potential for open header bag seals, compromising sterility.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the state of Florida.Recall #Z-2530-2025
Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 4, 2025
Halyard, CPT BASIC IR PACK. Model Number: 1646381.
Convenience kit.
Reason: Potential for open header bag seals, compromising sterility.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the state of Florida.Recall #Z-2531-2025
Open, ClassifiedPosted Sep 5, 2025·Initiated Jul 30, 2025
Brand Name: Fortress Introducer Sheath System
Product Name: Fortress Introducer Sheath System
Model/Catalog Number: 386594
Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
Reason: Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
Root cause: Under Investigation by firm
Recalling firm: Contract Medical International GmbHType: Introducer, CatheterDistribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, GA, KY, MA, MI, MO, NJ,
NY, OR, RI, SC, TN, TX and the countries of Switzerland, Hungary, Italy, France, Denmark, Austria, Australia, Belgium, Poland, Germany, Bulgaria, Kazakhstan, Finland, Ireland, South Korea, Taiwan, Israel, Spain, Vietnam, Malaysia, Czechia, Thailand, Libya, Great Britain, Chile, Slovakia, Slovenia, Croatia, Sweden, Argentina.Recall #Z-2532-2025
Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 5, 2025
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):
1. H74904526011;
2. H74904526052;
3. M0067101140;
4. M001151050;
5. M001151062;
6. M00566670.
(Interventional Cardiology, Peripheral Interventions)
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Syringe, Balloon Inflation, ExemptDistribution: Worldwide distribution.Recall #Z-2533-2025 Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 5, 2025
Boston Scientific Encore Advantage Kit, Material Numbers (UPN):
1. H74904527011;
2. H74904527052.
(Interventional Cardiology and Peripheral Interventions)
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Syringe, Balloon InflationDistribution: Worldwide distribution.Recall #Z-2534-2025 Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 5, 2025
Boston Scientific NephroMax Kit, Material Numbers (UPN):
1. M0062101180;
2. M0062101600.
(Urology)
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, NephrostomyDistribution: Worldwide distribution.Recall #Z-2535-2025 Open, ClassifiedPosted Sep 5, 2025·Initiated Aug 5, 2025
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN):
1. M0062251200,
2. M0062251210,
3. M0062251220,
4. M0062251230,
5. M0062251240,
6. M0062251260,
7. M0062251290,
8. M0062251300,
9. M0062251310.
10. M0062251350,
11. M0062251360,
12. M0062251370.
(Urology)
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Dilator, Catheter, UreteralDistribution: Worldwide distribution.Recall #Z-2536-2025 Open, ClassifiedPosted Sep 5, 2025·Initiated Oct 16, 2024
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Reason: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Root cause: Unknown/Undetermined by firm
Recalling firm: CORNEAT VISION, LTD.Type: Prosthesis, Eyelid Spacer/Graft, PolymerDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.Recall #Z-2537-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 24, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM Android App
Model/Catalog Number: SW12299
Software Version: version 2.8.0 and earlier
Product Description: Dexcom G7 CGM Android App SW12299
Component: Dexcom G7 Continuous Glucose Monitoring System
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 24, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM iOS App
Model/Catalog Number: SW12300
Software Version: version 2.8.0 and earlier
Product Description: Dexcom G7 CGM iOS App
Component: Dexcom G7 Continuous Glucose Monitoring System
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 24, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM watchOS App
Model/Catalog Number: SW13355
Software Version: versions 2.8.0 and earlier
Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app
Component: Dexcom G7 CGM iOS App
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 24, 2025
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System
Product Name: Dexcom ONE+ Android CGM App
Model/Catalog Number: SW14245
Software Version: versions 1.4.0 and earlier
Product Description: Dexcom ONE+ Androind CGM App
Component: Dexcom ONE+ Continuous Glucose Monitoring System
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 24, 2025
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System
Product Name: Dexcom ONE+ iOS CGM App
Model/Catalog Number: SW14244
Software Version: versions 1.4.0 and earlier
Product Description: Dexcom ONE+ iOS CGM App
Component: Dexcom ONE+ Continuous Glucose Monitoring System
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa
SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
Open, ClassifiedPosted Sep 4, 2025·Initiated May 30, 2025
Platelia Toxo IgM Catalog Number 26211
UDI Code: 03610520005552
The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
Reason: Due to a risk of false positive results that could lead to unnecessary medical treatment.
Root cause: Process control
Recalling firm: Bio-Rad Laboratories, Inc.Type: Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiDistribution: U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.Recall #Z-2515-2025 Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 16, 2025
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Reason: Potential for missing pins at tip of inserter.
Root cause: Process change control
Recalling firm: PREMIA SPINE LTDType: Prosthesis, Posterior Spinal ElementsDistribution: US Nationwide distribution in the state of Connecticut.Recall #Z-2516-2025