FDA Updates

Every medical device recall the FDA publishes, pulled live from openFDA's Device Recall database - the same records behind the FDA's own recall pages. No manual sync: this page re-fetches on its own, so a recall shows up here as soon as the FDA posts it. Not filtered to devices in our catalog.

openFDA last refreshed this dataset on September 5, 2026. New recalls appear here on the FDA's own publishing schedule.

59,129 recall(s)

Open, ClassifiedPosted Feb 3, 2026·Initiated Dec 19, 2025

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Root cause: Under Investigation by firm

Recalling firm: Siemens Medical Solutions USA, IncType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.Recall #Z-1241-2026

Open, ClassifiedPosted Feb 3, 2026·Initiated Dec 19, 2025

NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Root cause: Under Investigation by firm

Recalling firm: Siemens Medical Solutions USA, IncType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.Recall #Z-1242-2026

Open, ClassifiedPosted Feb 3, 2026·Initiated Dec 23, 2025

Focalyx Fusion

Reason: 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.

Root cause: Software change control

Recalling firm: Focalyx Technologies, LLC.Type: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.Recall #Z-1243-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-1224-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-1225-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-1226-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-1227-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-1228-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-1229-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-1230-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 6, 2026

PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Root cause: Component design/selection

Recalling firm: VANTIVE US HEALTHCARE LLCType: Separator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaDistribution: US Nationwide distribution.Recall #Z-1231-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Nov 7, 2025

Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

Reason: 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

Root cause: Process control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. O.U.S.: Austria, Brazil, China, France, Germany, Greece, India, Italy, Japan, Lebanon, Netherlands, South Korea, Spain, Switzerland, Taiwan and United KingdomRecall #Z-1232-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 5, 2026

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Reason: 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.

Root cause: Labeling Change Control

Recalling firm: Encore Medical, LPType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CARecall #Z-1233-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 5, 2026

EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C

Reason: 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.

Root cause: Labeling Change Control

Recalling firm: Encore Medical, LPType: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedDistribution: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CARecall #Z-1234-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Dec 23, 2025

CellMek SPS Sample Preparation System, REF: C44603, with software

Reason: 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.

Root cause: Software change control

Recalling firm: Beckman Coulter, Inc.Type: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisDistribution: Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL, OR, IL and the countries of AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, CH.Recall #Z-1235-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Jan 5, 2026

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States. AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491

Reason: 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.

Root cause: Under Investigation by firm

Recalling firm: Biomerieux IncType: Susceptibility Test Cards, AntimicrobialDistribution: Worldwide - US Nationwide distribution.Recall #Z-1236-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Dec 19, 2025

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

Reason: 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.

Root cause: Labeling mix-ups

Recalling firm: Tornier, IncType: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedDistribution: US Nationwide distribution.Recall #Z-1237-2026

Open, ClassifiedPosted Feb 2, 2026·Initiated Nov 2, 2025

MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

Reason: 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.

Root cause: Process design

Recalling firm: Medtronic MiniMed, Inc.Type: Automated Insulin Dosing Device System, Single Hormonal ControlDistribution: Worldwide - U.S. National distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The country of Israel.Recall #Z-1238-2026

Open, ClassifiedPosted Jan 30, 2026·Initiated Nov 10, 2025

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

Reason: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

Root cause: Under Investigation by firm

Recalling firm: Beckman Coulter, Inc.Type: Diluent, Blood CellDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.Recall #Z-1221-2026

Open, ClassifiedPosted Jan 30, 2026·Initiated Feb 17, 2024

Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.

Reason: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Root cause: Device Design

Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: US Nationwide distribution.Recall #Z-1222-2026