February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Hazard: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25
Hazard: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls 25GA Subretinal Injection Cannula VS0220.25
Hazard: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS
Hazard: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Las
Hazard: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3.
Hazard: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Hazard: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
February 11, 2026Medical DevicesFDA
Focalyx Technologies, LLC. recalls Focalyx Fusion
Hazard: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
February 11, 2026Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE
Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
February 11, 2026Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT AS
Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
February 11, 2026Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
February 11, 2026Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
February 11, 2026Medical DevicesFDA
Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin p
Hazard: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
February 11, 2026Medical DevicesFDA
Tornier, Inc recalls TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Hazard: A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
February 11, 2026Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem
Hazard: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
February 11, 2026Medical DevicesFDA
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603, with software
Hazard: Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
February 11, 2026Medical DevicesFDA
Encore Medical, LP recalls EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF:
Hazard: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
February 11, 2026Medical DevicesFDA
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Hazard: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
February 11, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:
Hazard: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Mode
Hazard: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Cata
Hazard: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
February 11, 2026Medical DevicesFDA
Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjun
Hazard: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.