The Recall Desk

State

Utah product recalls

73,584 recalls have nationwide distribution and so reach Utah. 4,909 additional recalls listed Utah specifically in their distribution scope.

What the numbers show

Total
4,909
Critical
524
Severe
1,349
Most recent
2026-10-14

Of the 4,909 recalls naming Utah we have scored against our rubric, 524 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,349 (27%) are Severe.

Which agencies issued them

These figures cover only the 4,909 recalls whose distribution notice names Utah specifically. The 73,584 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

551–575 of 78493

  • HighFDA (Devices)·Z-3164-2026·2026-09-23

    Nuclein DASH Rapid PCR Instrument Recalled for Software Issue

    Nuclein LLC is recalling 182 DASH Rapid PCR Instruments due to a software issue. The recall affects units distributed in 18 US states.

    Product
    Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3170-2026·2026-09-23

    GE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors

    GE Healthcare is recalling Workflow Core Services V8 because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3171-2026·2026-09-23

    GE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors

    GE Healthcare is recalling Core Services Hub V8 software because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3176-2026·2026-09-23

    Happiest Baby SNOO Sleep Sacks Recalled for Lack of FDA Review

    Happiest Baby, Inc. is recalling SNOO Sleep Sacks because they have not been reviewed for safety and effectiveness by the FDA.

    Product
    Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536 S2101-541 S2101-551 S2102-508-10 S2102-508-9 S2103-501…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3193-2026·2026-09-23

    Mirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure

    Mirion Technologies is recalling 783 Captus 4000e Thyroid Uptake Systems because a tension bolt may fail, causing the spring arm to fall unexpectedly.

    Product
    Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3212-2026·2026-09-23

    ICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage

    ICU Medical is recalling 185,688 CADD Yellow Medication Cassette Reservoirs because they may leak medication at the connector joint, potentially interrupting therapy or causing exposure to harmful agents.

    Product
    CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3179-2026·2026-09-23

    Embecta Medical Recalls Nano Pro Pen Needles Distributed as Commercial Devices

    Embecta Medical II LLC is recalling Nano Pro Un-Cannulated Demo Samples because investigational-use-only pen needles were inadvertently distributed as commercially marketed devices.

    Product
    EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3189-2026·2026-09-23

    Datex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling Aisys anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.

    Product
    Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3147-2026·2026-09-23

    Bayer Medical Care Recalls Stellant FLEX Syringe Kits Due to Sterilization Issues

    Bayer Medical Care is recalling 27,800 Stellant FLEX Syringe Kits because some may not have been properly sterilized due to a manufacturing issue.

    Product
    MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3167-2026·2026-09-23

    GE Healthcare Enterprise Archive V8 Software Recalled for Data Association Errors

    GE Healthcare is recalling Enterprise Archive V8 software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis.

    Product
    Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3182-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3142-2026·2026-09-23

    Philips PIC iX Essentials Patient Information System Software Recall

    Philips North America is recalling 312 units of the PIC iX Essentials patient information system due to a software malfunction that may cause the system to freeze.

    Product
    Philips PIC iX Essentials REF:867093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3197-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components manufactured with aged polyethylene material that may oxidize and increase wear.

    Product
    ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3169-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error

    GE Healthcare is recalling 116 Centricity PACS Server V7 systems because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3185-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implant Components Due to Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made from aged polyethylene. The material may oxidize and wear excessively, potentially causing device failure.

    Product
    BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3168-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors

    GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3166-2026·2026-09-23

    GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors

    GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3205-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Polyethylene Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components because aged polyethylene material may cause increased wear and device failure.

    Product
    SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3141-2026·2026-09-23

    Philips Patient Information Center iX Software Malfunction Recall

    Philips North America is recalling 7,359 Patient Information Center iX units due to a software malfunction that may cause the system to freeze and become unresponsive.

    Product
    Philips Patient Information Center iX REF:866389
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3145-2026·2026-09-23

    Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues

    Maquet is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity.

    Product
    Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3178-2026·2026-09-23

    restor3d Recalls Kinos Axiom Total Ankle Systems with Incorrect Cutting Guides

    restor3d Inc. is recalling two Kinos Axiom Total Ankle Systems because they were packaged with incorrect patient-specific cutting guides, which may lead to surgical complications.

    Product
    Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3209-2026·2026-09-23

    Medline Myringotomy Kits Recalled for Potential Sterility Compromise

    Medline Industries is recalling 60 Myringotomy Pack-LF kits due to open seals that may compromise sterility and lead to patient infection.

    Product
    Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
    Category
    Medical Device
    Distribution
    Distributed nationwide