Recalls & alerts

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

• openFDA · October 7, 2026Moderate risk

  American Nitrile Operations Llc : Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue…

  American Nitrile Operations LLC is recalling its Opportunity Flex blue nitrile patient examination gloves, models 72-50900 through 72-50904. The gloves may have tears, missing fingers, or debris, exposing healthcare workers and patients to infection or chemical hazards. Consumers should stop using the recalled gloves and follow the firm's recall instructions.

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• openFDA · October 7, 2026Moderate risk

  Olympus Corporation of the Americas : Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.

  The recall affects the Olympus M3 Gold Autoclavable Lateral Telescope 70, model M3-70A. The hazard is a discrepancy between sterilization parameters listed in the Instructions for Use and the Japanese package insert, affecting users in Japan. Consumers should contact Olympus Corporation of the Americas for further instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Version: Not Applicable…

  ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model 564019, a sterile cuff used during surgery. The cuff has an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective or non-sterile devices. Consumers should locate any affected cuffs, verify the expiration date, stop using them, and contact ASP Global for return or replacement.

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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 10) WHITE Model/Catalog Number: 564011 Software Version: Not Applicable…

  ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model 564011, 30" x 4" 2-line white. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect sterility and expose patients undergoing surgery to risk. Users should stop using affected cuffs and contact ASP Global for replacement or return.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Version: Not Applicable…

  ASP Global, LLC is recalling Expressaire Disposable Tourniquet Cuff, 34" x 4" 1-Line (CS 10) Blue, model 564012. 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 or non-sterile devices. Consumers should stop using affected cuffs, check expiration dates, and contact ASP Global for replacement or return.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicable Product Description:…

  The recall affects MPR Single Use Tourniquet Cuff 30" 2 Line (model DT-7030-02Q) made by ASP Global, LLC. 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, return, or discard them.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7.…

  Philips is recalling its Ingenia Elition S and Ingenia Elition X MRI systems with certain software versions. The systems export incorrect diffusion directions in DTI scans, which can cause third-party tractography software to misprocess brain nerve fiber mapping. Users should stop using affected Enhanced MR DICOM exports and contact Philips for a correction.

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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 10) Model/Catalog Number: 564001 Software Version: Not Applicable…

  Expressaire disposable tourniquet cuffs, model 564001, 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 possible failure. Consumers should stop using affected cuffs and contact ASP Global for replacement or return.

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• openFDA · October 7, 2026Moderate risk

  Shanghai United Imaging Healthcare Co., Ltd. : Computed Tomography X-ray System, Model: uCT 760 with software

  Shanghai United Imaging Healthcare is recalling its Computed Tomography X-ray System, Model uCT 760 with software. A software problem can hide patient images when certain functions are used, possibly requiring rescans for patients. Consumers should contact their imaging facility or the manufacturer for guidance.

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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 GS with software

  Shanghai United Imaging Healthcare Co., Ltd. is recalling its Positron Emission Tomography and Computed Tomography System, model uMI Panorama GS with software. A software problem can prevent patient images from appearing on the Patient Administration interface, which may require rescans for patients scanned nationwide. Consumers should contact the facility where they were scanned to ask whether a rescan is needed.

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• openFDA · October 7, 2026Moderate risk

  Olympus Corporation of the Americas : Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System

  The recall affects the Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, model P580-025, an accessory for the OLYSENSE Hub System. The cable may cause video dropout or blackout in high-power mode, affecting users of the system. Consumers should stop using the cable and contact Olympus for further instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicable Product Description:…

  ASP Global, LLC is recalling MPR Single Use Tourniquet Cuff 44" 1 Line (model DT-7044-01Q). The cuffs are labeled with a 10-year shelf life but only have a validated 5-year shelf life, exposing patients to risk if used beyond that period. Consumers should stop using affected cuffs and contact ASP Global for replacement or instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applicable Product Description:…

  ASP Global, LLC is recalling the MPR brand Single Use Tourniquet Cuff 15" 2 Line, model DT-7115-02Q. 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 surgical patients to potentially expired sterile devices. Consumers should check the expiration date and stop using any affected cuff that is beyond the 5-year validated shelf life.

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• openFDA · October 7, 2026Moderate risk

  Wright Medical Technology, Inc. : CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System

  Wright Medical Technology's CHARLOTTE CLAW Screw, REF 40122716, for the CLAW II Polyaxial Compression Plating System is recalled. The screwheads have missing threads, preventing secure plate engagement, which may prolong surgery or require an alternative method. Consumers should contact their healthcare provider to determine if they have the affected screw and what to do.

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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 with software

  Shanghai United Imaging Healthcare Co., Ltd. is recalling its Positron Emission Tomography and Computed Tomography System, model uMI Panvivo with software. A software problem prevents patient images from appearing on the Patient Administration interface when Split or Local function is enabled and multiple RIS exams are merged, which may require rescans for patients. The firm initiated a voluntary recall of the affected systems.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version: Not Applicable…

  ASP Global's Disposable Tourniquet Cuff, 30" x 4" 2-Line, White, model ASP-564011, is 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 expired sterile devices. Consumers should check the manufacture date and stop using any cuff older than five years.

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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, LAVH , Catalog Number: PB63VHSTC

  Cardinal Health 200, LLC is recalling Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets, catalog number PB63VHSTC. The handpieces may leak fluid that pools on the floor, posing a slip and fall hazard to users. Consumers should stop using the affected kits and contact Cardinal Health for further instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: Not Applicable Product…

  ASP Global is recalling its Disposable Tourniquet Cuff, 18" x 4" 1-Line, Red, model ASP-564006. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may affect sterility and patient safety during surgery. Consumers should stop using affected cuffs, check the manufacture date, and return or dispose of any product older than five years.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Software Version: Not…

  Expressaire disposable tourniquet cuffs, model A70107000, are affected. The cuffs show an incorrect expiration date, claiming a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially unsafe use. Consumers should stop using these cuffs and contact ASP Global for instructions.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7.…

  Philips is recalling its Ingenia Ambition S and Ingenia Ambition X MRI systems. The systems may export incorrect diffusion data in DTI scans, which can lead to wrong brain tractography results for patients when used with third-party software. Users should stop using affected software versions and contact Philips for instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Version: Not Applicable…

  ASP Global, LLC is recalling its Expressaire Disposable Tourniquet Cuff, 12" x 3.5" 2-Line (CS 10) Plum, model 564003. The cuffs are labeled with a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective or non-sterile devices. Consumers should stop using affected cuffs, check expiration dates, 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, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software Version: Not Applicable…

  ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model A70107004, a sterile cuff used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect patients during surgical procedures. Consumers should stop using affected cuffs and contact ASP Global for replacement or return.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 Software Version: Not Applicable…

  ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model 564005, a sterile cuff used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect patients during surgical use. Users should stop using affected cuffs and contact ASP Global for replacement or return.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;

  Philips is recalling its Ingenia Blue Seal SE and Blue Seal XE MRI systems, model numbers 782185 and 782192, 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 misprocess brain nerve mapping, exposing patients to potentially inaccurate results. Users should contact Philips to arrange for a software correction or 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 Astound with software

  Shanghai United Imaging Healthcare Co., Ltd. is recalling its Computed Tomography X-ray System, Model uCT ATLAS Astound with software. A software problem can hide patient images on the Patient Administration interface, possibly requiring rescans for patients. The voluntary, firm-initiated recall means patients should contact their imaging facility for guidance.

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• openFDA · October 7, 2026Moderate risk

  Heraeus Medical GmbH (Dental Division) : PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled…

  Heraeus Medical GmbH is recalling PALACOS MV+G pro 40 and pro 80 bone cement kits, models 5081290 and 5081291. The cement may leak monomer liquid, exposing patients and healthcare workers to potential harm. Consumers should stop using affected kits and contact Heraeus Medical for instructions.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Version: Not Applicable…

  ASP Global's Expressaire Disposable Tourniquet Cuff, model 564013, is recalled. The cuff has an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially expired sterile devices. Consumers should stop using the recalled cuffs and contact ASP Global for return or replacement.

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• openFDA · October 7, 2026Moderate risk

  Alere San Diego, Inc. : Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074,…

  Fisher Scientific, Henry Schein, Alere, Cardinal Health, Medline, and Pro Advantage urine pregnancy tests are affected. The tests may detect low hCG levels and give false positive results, affecting people who use them. Consumers should stop using the recalled tests and contact the manufacturer for instructions.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;

  Philips North America is recalling SmartPath to MR 7700 systems with model numbers 782178 and 782207 and software versions R11, R12, and R13. The affected software exports diffusion tensor imaging scans with incorrect diffusion directions, which can cause third-party tractography software to misprocess brain fiber pathway data. Users should stop using the affected software for Enhanced MR DICOM exports and contact Philips for a correction.

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• openFDA · October 7, 2026Moderate risk

  Philips North America : MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;

  Philips MR 5300 systems with model numbers 782110, 782152, 782156, or 782196 and software versions R11, R12, or R13 are affected. The hazard is that DTI scan exports contain incorrect diffusion directions, so third-party tractography software cannot correctly reconstruct brain nerve pathways, affecting patients whose scans are analyzed this way. Users must contact Philips for instructions on correcting the software.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicable Product Description:…

  Summary being prepared.

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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 10) GREEN Model/Catalog Number: 564014 Software Version: Not Applicable…

  Summary being prepared.

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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 CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version: Not Applicable…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  Bard Peripheral Vascular Inc : EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicable Product Description:…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 Software Version: Not Applicable…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q Software Version: Not Applicable…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  Micro Therapeutics, Inc. : Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  Olympus Corporation of the Americas : Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  Percussionaire Corporation : Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicable Product Description:…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Version: Not Applicable…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version: Not Applicable…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  Illumina, Inc. : NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130

  Summary being prepared.

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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, 1-LINE (CS 12) ORANGE Model/Catalog Number: A70107016 Software…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  Percussionaire Corporation : In-Line Valve, Product Number: P5-TEE

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q Software Version: Not Applicable Product Description:…

  Summary being prepared.

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• openFDA · October 7, 2026Moderate risk

  ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 Software Version: Not Applicable…

  Summary being prepared.

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• 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…

  Summary being prepared.

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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.