Recalls & alerts

602 alerts recorded, refreshed every six hours. Filter by source or category.

• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q Software Version: Not Applicable…

  ASP Global, LLC is recalling MPR Single Use Tourniquet Cuff 26" Dual Bladder, 2 Line, model DB-7024-02Q. The cuffs have an incorrect expiration date, labeled with a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potential product failure. Consumers should stop using affected cuffs, verify the expiration date, and follow the recall instructions for return or replacement.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;

  Philips North America is recalling Upgrade dStream, model REF 782127, software versions R11, R12, and R13. The affected software exports incorrect diffusion directions in Enhanced MR DICOM DTI scans, which can cause third-party tractography software to misprocess brain nerve fiber mapping. Users should stop using the affected software versions and follow the firm's instructions.

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• openFDA · October 7, 2026High risk

  Draeger, Inc. : VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.

  Draeger, Inc. is recalling its VentStar Resus Neo neonatal disposable breathing circuit, part number MP00310. The hose may have cracks, causing leakage or detachment, which exposes neonatal patients to risk. Consumers should stop using the affected product and contact Draeger for instructions.

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• openFDA · October 7, 2026Moderate risk

  Alere San Diego, Inc. : Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;…

  Fisher Scientific Sure-Vue, Beckman Coulter ICON 25, Henry Schein One Step+, Alere hCG Combo, and Pro Advantage pregnancy tests are affected. The tests may detect low hCG levels and give false positive results, exposing users worldwide to incorrect results. Consumers should stop using these tests and follow the recall instructions.

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• openFDA · October 7, 2026Moderate risk

  Shanghai United Imaging Healthcare Co., Ltd. : Computed Tomography X-ray System, Model: uCT ATLAS with software

  Shanghai United Imaging Healthcare is recalling its Computed Tomography X-ray System, model uCT ATLAS with software. A software problem can hide patient images when certain functions are used, possibly requiring rescans and exposing patients to extra radiation. Users should stop using the affected function and contact the company for a software update.

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• openFDA · October 7, 2026Moderate risk

  Shanghai United Imaging Healthcare Co., Ltd. : Computed Tomography X-ray System, Model: uCT 780 with software

  Shanghai United Imaging Healthcare Co., Ltd. is recalling its Computed Tomography X-ray System, model uCT 780 with software. A software problem can hide patient images when certain functions are used, possibly requiring rescans, affecting patients scanned with this system nationwide. Patients should contact their healthcare provider or imaging facility to ask about their scan and any needed follow-up.

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• openFDA · October 7, 2026Moderate risk

  Shanghai United Imaging Healthcare Co., Ltd. : Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software

  Shanghai United Imaging Healthcare's uMI Panvivo S Positron Emission Tomography and Computed Tomography System with software is affected. A software problem can hide patient images when Split or Local function is used and multiple exams are merged, possibly requiring rescans for patients. The firm initiated a voluntary recall, so consumers should contact their imaging provider for instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 Software Version: Not Applicable…

  ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model A70107012, a sterile cuff used to control blood flow during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may expose surgical patients to a product past its safe usable life. Consumers should immediately stop using affected cuffs, check expiration dates, and contact ASP Global for replacement.

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• openFDA · October 7, 2026Moderate risk

  Philips North America Llc : Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

  Philips Spectral CT 7500 with software V5.2.x is affected. The bolus tracking application may crash and keep scanning after the contrast threshold, exposing patients to extra radiation. Users must follow the FDA-mandated recall instructions for the affected software.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 Software Version: Not Applicable Product…

  ASP Global is recalling its Disposable Tourniquet Cuff, 18" x 4" 2-Line, Red, model ASP-564007, distributed nationwide. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could expose patients to non-sterile or ineffective devices during surgery. Consumers and healthcare providers should stop using affected cuffs and follow the firm's recall instructions for return or disposal.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version: Not Applicable Product…

  ASP Global, LLC is recalling its Expressaire Disposable Tourniquet Cuff, 38" x 4" 1-Line, model 564044. The cuffs have an incorrect expiration date, labeled with a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective devices. Consumers should check the expiration date on affected cuffs and contact ASP Global for instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Version: Not Applicable…

  ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model 564007, distributed nationwide. The cuffs are labeled with a 10-year shelf life instead of the correct 5 years, which could affect their performance during surgery and put patients at risk. Consumers should stop using affected cuffs and contact ASP Global for return or replacement.

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• openFDA · October 7, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number:…

  Cardinal Health 200, LLC is recalling Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets, including GU Davinci kits and Colorectal packs with specific catalog numbers. The tube sets may leak fluid from the handpiece onto the floor, creating a slip and fall hazard for users. Consumers should stop using the affected kits and follow the recall notice.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T),…

  Philips North America is recalling Evolution upgrade 1.5T and 3.0T MR systems with specific model numbers. The systems export diffusion tensor imaging data with incorrect diffusion directions, which can cause third-party tractography software to misprocess brain nerve fiber mapping. Users should contact Philips North America for instructions on correcting the issue.

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• openFDA · October 7, 2026Moderate risk

  Shanghai United Imaging Healthcare Co., Ltd. : Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software

  Shanghai United Imaging Healthcare's uMI Panorama 35 positron emission tomography and computed tomography system with software is affected. A software problem can hide patient images on the Patient Administration interface, possibly requiring rescans for patients. Consumers should contact their imaging facility or the manufacturer for recall instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version: Not Applicable Product…

  ASP Global disposable tourniquet cuffs, model ASP-564012, are affected. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially compromised sterility. Consumers should check the expiration date on their cuffs and contact ASP Global for replacement if affected.

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• openFDA · October 7, 2026Moderate risk

  Shanghai United Imaging Healthcare Co., Ltd. : Computed Tomography X-ray System, Model: uCT 550 with software

  Shanghai United Imaging Healthcare Co., Ltd. is recalling its Computed Tomography X-ray System, Model uCT 550 with software. A software problem when Split or Local function is enabled and multiple RIS exams are merged can hide patient images, possibly requiring rescans for patients. Consumers should contact their imaging facility or healthcare provider for guidance and follow-up.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262…

  Philips is recalling its Ingenia 1.5T, 1.5T CX, and 1.5T S MRI systems with software versions R11, R12, and R13. The affected systems export diffusion tensor imaging scans with incorrect diffusion directions, which can cause third-party tractography software to misreconstruct brain nerve fiber pathways. Users should stop using the affected export feature and contact Philips for a software correction.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A70107014 Software…

  ASP Global LLC is recalling Expressaire Disposable BB Tourniquet Cuffs, model A70107014, used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially unsafe devices. Consumers should stop using affected cuffs, check the expiration date, and contact ASP Global for return or replacement.

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• openFDA · October 7, 2026Moderate risk

  Penumbra Inc. : Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT…

  Penumbra Inc. is recalling its Penumbra System RED 62 Reperfusion Catheter, model THNDRRED62SKIT. The catheter may fracture during use, posing a risk to patients undergoing procedures. Consumers should contact their healthcare provider or Penumbra Inc. for instructions on returning the device.

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• openFDA · October 7, 2026High risk

  Medline Industries, LP : Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094…

  Medline Industries is recalling Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, specifically hand pendants. The hand control pendant and wiring may overheat, causing smoking, sparking, melting, burning, or fire, affecting users nationwide and in Puerto Rico, Guam, Bermuda, Canada, and Panama. Consumers should stop using the affected pendants and contact Medline Industries for further instructions.

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• openFDA · October 7, 2026Moderate risk

  American Nitrile Operations Llc : Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile…

  American Nitrile Operations LLC is recalling Performance Pro blue nitrile examination gloves, models 72-RM50601 through 72-RM50604. The gloves may have tears, missing fingers, or debris, exposing healthcare personnel and patients to infectious pathogens or chemical agents. Consumers should stop using the affected gloves and follow the recall notice for return instructions.

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• openFDA · October 7, 2026Moderate risk

  Percussionaire Corporation : Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual

  The recall affects Percussionaire Corporation's Intrapulmonary Percussive Ventilation IPV-2C and Phasitron 5 devices. Using these devices with volatile anesthetic delivery systems can change anesthetic levels, causing dangerous effects in patients. Consumers should read the updated warning and stop using the device with volatile anesthetic systems.

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• openFDA · October 7, 2026Moderate risk

  Custom Interventional Pain Management, LLC : Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B…

  The recall affects Mastisol Skin Adhesive in surgical convenience trays and kits from Ferndale Laboratories, Medline, and Custom Interventional Pain Management. Manufacturing issues with the liquid skin adhesive pose a hazard to patients undergoing procedures using these trays. Consumers should stop using affected kits and follow the firm's recall instructions for return.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software Version: Not…

  ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model A70107008, a 24x4 inch sterile cuff used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5-year shelf life, which may expose patients to a device that is no longer safe or effective. Consumers and healthcare providers should stop using affected cuffs and contact ASP Global for replacement or return.

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• openFDA · October 7, 2026Moderate risk

  Volcano Corp : Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

  Philips IntraSight Plus devices with reference numbers 797423 and 797417 are recalled. The software may mix up image data between patients, risking incorrect diagnosis or treatment for those patients. Consumers should contact their doctor or Philips for guidance.

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• openFDA · October 7, 2026Moderate risk

  American Contract Systems Inc : Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP…

  American Contract Systems Inc medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays are affected. The contaminated wipes can cause skin irritation, erythema, or mild inflammation, and discarding them may increase infection risk for patients. Consumers should stop using the affected kits and contact American Contract Systems Inc for instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable…

  ASP Global's Expressaire Disposable Tourniquet Cuff, model 553322, is affected. The cuffs have an incorrect expiration date, labeled with a 10-year shelf life instead of the validated 5 years, exposing patients to potentially ineffective sterilization during surgery. Consumers should stop using affected cuffs and contact ASP Global for instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version: Not Applicable…

  ASP Global is recalling its Disposable Tourniquet Cuff, 12" x 3.5" 2-Line, Plum, model ASP-564003. The cuffs have an incorrect expiration date showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective sterilization. Consumers should check the expiration date on affected cuffs and stop using them if they are older than five years, then follow the recall instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Version: Not Applicable…

  ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model A70107007, a sterile cuff used to control blood flow during surgery. The cuffs, made between September 2016 and March 2023, carry an incorrect 10-year expiration date instead of the validated 5-year shelf life, exposing patients to potentially ineffective or non-sterile devices. Consumers should stop using affected cuffs and contact ASP Global for replacement or return instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Version: Not Applicable…

  ASP Global, LLC is recalling Expressaire Disposable Tourniquet Cuffs, model 564010, distributed nationwide. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may affect sterility and function for surgical patients. Consumers should stop using affected cuffs, check expiration dates, and contact ASP Global for replacement.

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• openFDA · October 7, 2026Moderate risk

  SPECTRUM MEDICAL SRL : Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product…

  The recall affects the Quantum PureFlow Standard Heat Exchanger High Flow 3/8, model HX55W-S0, made by Spectrum Medical. A blood-to-glycol leak in the heat exchanger can expose patients to glycol during cardiopulmonary bypass procedures. Consumers should stop using the recalled device and contact Spectrum Medical for instructions.

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• openFDA · October 7, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW…

  Cardinal Health is recalling Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets used in gynecologic laparoscopy and robotic procedures. The handpieces may leak fluid onto the floor, creating a slip and fall hazard for operating room staff. Consumers should stop using the affected kits and contact Cardinal Health for instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software Version: Not…

  Expressaire Disposable Tourniquet Cuff, model 564017, made by ASP Global, is being recalled. The cuff has an incorrect expiration date showing a 10-year shelf life instead of the validated 5 years, putting surgical patients at risk of using a non-sterile or ineffective device. Consumers should stop using affected cuffs, verify the expiration date, and contact ASP Global for a replacement.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;

  Philips North America MR 7700 systems with model numbers 782120, 782153, 782155, and 782199 and software versions R11, R12, and R13 are affected. The hazard is incorrect diffusion direction data in Enhanced MR DICOM exports, which can cause third-party tractography software to misprocess DTI scans for brain imaging. The firm initiated a voluntary recall.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicable Product Description:…

  The recall affects MPR brand Single Use Tourniquet Cuff 44" 2 Line, model DT-7044-02Q. The cuffs have an incorrect expiration date, showing 10 years instead of the validated 5-year shelf life, exposing surgical patients to risk of device failure. Consumers should stop using affected cuffs and contact ASP Global for return or replacement instructions.

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• openFDA · October 7, 2026Moderate risk

  Percussionaire Corporation : Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC

  Percussionaire Corporation is recalling its Intrapulmonary Percussive Ventilation (IPV HC) and Phasitron (P5-HC) devices. Using these devices with volatile anesthetic delivery systems can cause unsafe anesthesia levels, leading to serious heart, brain, or sedation problems in patients. Consumers must stop using IPV with volatile anesthetics and follow the updated warning label.

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• openFDA · October 7, 2026Moderate risk

  Shanghai United Imaging Healthcare Co., Ltd. : Computed Tomography X-ray System, Model: uCT 530 with software

  Shanghai United Imaging Healthcare's Computed Tomography X-ray System, model uCT 530 with software, is affected. A software problem can hide patient images on the Patient Administration interface, possibly requiring rescans, affecting patients scanned with this system nationwide. Consumers should contact their healthcare provider to determine if their imaging was affected and what to do next.

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• openFDA · October 7, 2026Moderate risk

  Merit Medical Systems, Inc. : Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF:…

  Merit Medical Systems' Embosphere microspheres in 500-700, 700-900, and 900-1200 micrometer 2 mL syringes are affected. The packaging may have holes that compromise the sterile barrier, exposing patients to infection during embolization procedures. Consumers should contact Merit Medical Systems for return and replacement instructions.

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• openFDA · October 7, 2026Moderate risk

  SPECTRUM MEDICAL SRL : Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A…

  Spectrum Medical's Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W (model HX55V-S0W) is affected. A blood-to-glycol leak in the heat exchanger poses a hazard to patients during cardiopulmonary bypass. Consumers should follow the recall instructions from Spectrum Medical.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A70107017 Software…

  ASP Global is recalling Expressaire Disposable BB Tourniquet Cuffs, model A70107017, distributed nationwide. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective devices. Consumers and healthcare providers should stop using affected cuffs and return them to ASP Global.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Software Version: Not…

  ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model A70107001, an 8-inch by 2.5-inch light blue sterile cuff used during surgery. The cuffs, made between September 2016 and March 2023, carry an incorrect 10-year expiration date instead of the validated 5-year shelf life, which could expose patients to ineffective or unsafe devices. Consumers should check the expiration date on affected cuffs and stop using them, then contact ASP Global for instructions on returning or replacing the product.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;

  Philips is recalling Ingenia 3.0T and 3.0T CX MRI systems with software versions R11, R12, and R13. The DTI scan exports contain incorrect diffusion directions, so third-party tractography software may misprocess brain nerve pathway images, affecting patients. Users should stop using the affected software and contact Philips for correction.

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• openFDA · October 7, 2026High risk

  Medline Industries, LP : Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE

  Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories are affected. The hand control pendant and wiring may overheat, causing smoking, sparking, melting, burning, or fire, posing a risk to users. Consumers should stop using the affected beds and contact Medline Industries for a remedy.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Version: Not Applicable…

  ASP Global LLC is recalling Expressaire Disposable Tourniquet Cuffs, model 553323, 30 by 4 inches. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective blood flow control. Consumers should locate affected cuffs, verify the expiration date, and stop using or return them to the company.

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• openFDA · September 30, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A

  Medline Industries is recalling its Convenience Kit MAJOR PACK, catalog number DYNJ81325A. The neurological sponges inside may have elevated endotoxin levels, posing health risks like fever, nausea, or neurovascular problems for patients. Consumers should stop using the kits and contact Medline for instructions on return or replacement.

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• openFDA · September 30, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number:…

  Medline Industries is recalling certain Convenience Kits, including PEDS SINUS PACK, SINUS PACK-LF, NASAL-LF, ENT PACK, and EENT PACK, with specific catalog numbers. The kits contain neurological sponges with potentially elevated endotoxin levels, which can cause febrile response, hypotension, nausea, or other serious health issues for patients. Consumers should stop using the recalled kits and follow the recall instructions for return or disposal.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1.…

  Philips SmartPath to dStream for 1.5T, 3.0T, XR and 3.0T, and Ingenia Elition X are affected. A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted beyond available system memory, affecting patients and operators. Consumers should avoid manually adjusting scan parameters that exceed the system's memory capacity.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283…

  Philips is recalling its Achieva 1.5T, Achieva 1.5T Conversion, and Achieva 1.5T Initial systems. A software issue can terminate an examination during image reconstruction if manual scan settings exceed available memory, affecting patients receiving MRI scans. Consumers should contact their healthcare provider or Philips for further instructions.

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• openFDA · September 30, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY…

  Medline Industries is recalling certain Medline Convenience Kits, including craniotomy packs with catalog numbers DYNJT8784 and DYNJ0369348Q through DYNJ0369348T. The kits contain neurological sponges with potentially elevated endotoxin levels, which can cause fever, nausea, low blood pressure, or neurovascular problems in patients. Consumers should stop using these kits, check the catalog numbers, and follow the firm's return instructions.

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Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.