Open, ClassifiedPosted Jun 17, 2025·Initiated Aug 12, 2022
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Reason: Potential presence of residual adhesive material on the mesh surface.
Root cause: Process control
Recalling firm: Chamberlain Technologies LLCType: Mesh, Surgical, PolymericDistribution: US distribution to states of: Illinois, Nebraska, & CaliforniaRecall #Z-1984-2025
Open, ClassifiedPosted Jun 17, 2025·Initiated Aug 12, 2022
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Reason: Potential presence of residual adhesive material on the mesh surface.
Root cause: Process control
Recalling firm: Chamberlain Technologies LLCType: Mesh, Surgical, PolymericDistribution: US distribution to states of: Illinois, Nebraska, & CaliforniaRecall #Z-1985-2025
Open, ClassifiedPosted Jun 17, 2025·Initiated Aug 12, 2022
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Reason: Potential presence of residual adhesive material on the mesh surface.
Root cause: Process control
Recalling firm: Chamberlain Technologies LLCType: Mesh, Surgical, PolymericDistribution: US distribution to states of: Illinois, Nebraska, & CaliforniaRecall #Z-1986-2025
Open, ClassifiedPosted Jun 16, 2025·Initiated May 15, 2025
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).
Reason: Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Root cause: Process change control
Recalling firm: Cook IncorporatedType: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution.Recall #Z-1902-2025
Open, ClassifiedPosted Jun 16, 2025·Initiated May 12, 2025
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
Reason: Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Root cause: Nonconforming Material/Component
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.Recall #Z-1943-2025
Open, ClassifiedPosted Jun 16, 2025·Initiated May 12, 2025
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3)
Reason: Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Root cause: Nonconforming Material/Component
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.Recall #Z-1944-2025
Open, ClassifiedPosted Jun 16, 2025·Initiated May 12, 2025
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
Reason: Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Root cause: Nonconforming Material/Component
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.Recall #Z-1945-2025
Open, ClassifiedPosted Jun 16, 2025·Initiated May 12, 2025
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1),
STK-DO-013 (MT27409-1),
STK-DO-103 (MT27409-2),
STK-DO-109 (MT27409-2)
Reason: Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Root cause: Nonconforming Material/Component
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.Recall #Z-1946-2025
Open, ClassifiedPosted Jun 13, 2025·Initiated Apr 25, 2025
AcoSound. Model Number: LW12-BTE-M
Reason: Three issues
1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer.
2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer.
3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.
Root cause: Labeling design
Recalling firm: HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.Type: Hearing Aid, Air-Conduction With Wireless Technology, Over The CounterDistribution: US Nationwide distribution in the state of New York.Recall #Z-1976-2025
Open, ClassifiedPosted Jun 13, 2025·Initiated Sep 24, 2024
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Reason: Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Root cause: Use error
Recalling firm: Orthofix SrlType: Rod, Fixation, Intramedullary And AccessoriesDistribution: US: Unknown, OUS: UnknownRecall #Z-1977-2025
Open, ClassifiedPosted Jun 13, 2025·Initiated Jan 24, 2025
Brand Name: MiniDock
Product Name: Integrated Nucleic Acid Testing Device
Model/Catalog Number: PM001
Software Version: N/A
Product Description: 1. Product Overview
1.1 Product Name: Integrated Nucleic Acid Testing Device
Brand Name: MiniDock
1.2 Model: PM001
2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging.
Component: No
Reason: Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Root cause: No Marketing Application
Recalling firm: Guangzhou Pluslife Biotech Co., Ltd.Type: Coronavirus Antigen Detection Test System.Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papua New Guinea, Indonesia, South Africa, Zimbabwe, Brazil, Tunisia, Samoa, Algeria, Romania, Czech Republic, Thailand, South Korea, Malaysia, Fiji, Nepal, Peru, Mexico, Bahamas, Chile, India, Germany, France, Portugal, Vietnam, Spain, Poland, Latin American Region, Italy, Cameroon, Slovakia, Greece, Hungary Bahrain, Estonia, and Ukraine.Recall #Z-1978-2025
Open, ClassifiedPosted Jun 13, 2025·Initiated Jan 24, 2025
Brand Name: Pluslife SARS-CoV-2 Card
Product Name: SARS-CoV-2 Nucleic Acid Testing Card
Model/Catalog Number: RM1010202
Software Version: N/A
Product Description: 1. Product Overview
Product Name: SARS-CoV-2 Nucleic Acid Testing Card
Trade Name: Pluslife SARS-CoV-2 Card
2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs).
Component: NO
Reason: Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Root cause: No Marketing Application
Recalling firm: Guangzhou Pluslife Biotech Co., Ltd.Type: Coronavirus Antigen Detection Test System.Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papua New Guinea, Indonesia, South Africa, Zimbabwe, Brazil, Tunisia, Samoa, Algeria, Romania, Czech Republic, Thailand, South Korea, Malaysia, Fiji, Nepal, Peru, Mexico, Bahamas, Chile, India, Germany, France, Portugal, Vietnam, Spain, Poland, Latin American Region, Italy, Cameroon, Slovakia, Greece, Hungary Bahrain, Estonia, and Ukraine.Recall #Z-1979-2025
Open, ClassifiedPosted Jun 13, 2025·Initiated May 8, 2025
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Reason: Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Root cause: Device Design
Recalling firm: Ohio Medical CorporationType: Generator, Oxygen, PortableDistribution: US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.Recall #Z-1980-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated Apr 13, 2025
Microtek Patient Drape ECOLAB
AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN
UDI code: (01)10748426139986
AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN
UDI code: (01)10748426139429
These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.
Reason: Due to non-sterile products being labeled as sterile
Root cause: Labeling Change Control
Recalling firm: Microtek Medical, Inc.Type: Drape, Surgical, ExemptDistribution: U.S.: AL. AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, and VA
O.U.S.: N/ARecall #Z-1963-2025 Open, ClassifiedPosted Jun 12, 2025·Initiated May 12, 2025
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Reason: Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: US Nationwide distribution.Recall #Z-1964-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated Apr 24, 2025
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Reason: Software issue that could potentially lead to the device tipping over from Balance Mode.
Root cause: Software design
Recalling firm: Mobius Mobility LLCType: Wheelchair, Stair ClimbingDistribution: US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.Recall #Z-1965-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated May 13, 2025
Allon 2001. Part Number: 200-00263
Reason: An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if:
1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or
2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
Root cause: Device Design
Recalling firm: Belmont Instrument LLCType: System, Thermal RegulatingDistribution: Worldwide - US Nationwide distribution in the states of CA, DC, LA, MA, NM, PA, TX, VA, WA and the countries of Belgium, Bolivia (Plurinational State of), Brazil, Canada, Colombia, Israel, Italy, Portugal, Romania, Sweden, Taiwan (Province of China), Thailand, United Kingdom.Recall #Z-1966-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated Nov 1, 2023
Brand Name: Guardian 2 System
Product Name: Guardian System 2 Controller
Model/Catalog Number: GS-2.5-C
Software Version: 2.5.4-59 (Fix)
Reason: A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Root cause: Software design
Recalling firm: Turncare, IncType: Mattress, Air Flotation, Alternating PressureDistribution: US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, ConnecticutRecall #Z-1967-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated Aug 10, 2023
Brand Name: Guardian 2 System
Product Name: Guardian System 2 Controller
Model/Catalog Number: GS-2.5-C
Software Version: 2.5.4-69 (Fix)
Reason: A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Root cause: Software design
Recalling firm: Turncare, IncType: Mattress, Air Flotation, Alternating PressureDistribution: US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.Recall #Z-1968-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated May 28, 2025
Azurion R1.x and R2.x systems;
Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282;
Software Version: All software versions;
Reason: A software issue was identified in the internal communication process between the system
software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, IRAN, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.