The Recall Desk

State

Colorado product recalls

72,984 recalls have nationwide distribution and so reach Colorado. 6,941 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,941
Critical
1,218
Severe
1,507
Most recent
2026-09-09

Of the 6,941 recalls naming Colorado we have scored against our rubric, 1,218 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,507 (22%) are Severe.

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6526–6550 of 79925

  • SevereFDA (Devices)·Z-1865-2025·2025-06-18

    Z-800 Infusion System recalled for unverified software installation

    Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.

    Product
    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V413000·2025-06-18

    Mazda CX-50 airbag module software may cause improper deployment

    Mazda is recalling certain CX-50 Hybrid and CX-50 vehicles because incorrectly configured module software may cause the airbag to deploy improperly. All affected vehicles are under dealer control.

    Product
    MAZDA — MAZDA CX-50 HYBRID, CX-50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2025·2025-06-18

    Celecoxib Capsules 200 mg recalled for foreign tablets inside bottles

    Alembic Pharmaceuticals is recalling Celecoxib 200 mg capsules after a customer found a Tadalafil 5 mg tablet inside a sealed 500-count bottle. The contamination was discovered through a customer complaint.

    Product
    Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1936-2025·2025-06-18

    Philips SmartPath to dStream 1.5T MRI Gradient Coil Fire Risk

    Philips SmartPath to dStream for 1.5T MRI systems are recalled due to potential gradient coil component failure that may produce smoke and fire, posing risks of inhalation injury, burns, asphyxia, and death.

    Product
    SmartPath to dStream for 1.5T¿; Product Number: 782146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2025·2025-06-18

    Dietary Supplement Electro Buzz Recalled for Undeclared Active Pharmaceutical Ingredients

    SAINI TRADE INC is recalling ELECTRO BUZZ dietary supplement (lot KT-1ST-43-01-07/2024, expiring 10/15/2026) distributed nationwide. Laboratory testing found undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.

    Product
    ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0488-2025·2025-06-18

    Sulfamethoxazole and Trimethoprim Tablets Recalled for Microbial Contamination

    Amneal Pharmaceuticals is recalling Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg) nationwide due to microbial contamination that may cause black spots on tablets. The contamination affects non-sterile products distributed across the USA.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1953-2025·2025-06-18

    Tecfen Medical 20G MVR Sideport Knife ophthalmic sterility recall

    Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312) ophthalmic knives due to sterility assurance concerns. The recall affects 38 units distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1869-2025·2025-06-18

    Blood Products Administration Set Filter Mis-Assembly Recall

    Fresenius Kabi USA is recalling IVENIX INFUSION SYSTEM LVP Blood Products Administration Sets due to a mis-assembly error that may prevent the drip chamber filter from properly filtering large blood particulates.

    Product
    IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1934-2025·2025-06-18

    Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall

    Philips is recalling Intera 1.5T Omni/Stellar MRI systems due to a gradient coil component failure that can produce smoke and fire, risking patient and operator injury or death.

    Product
    Intera 1.5T Omni/Stellar; Product Number: 781104;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2025·2025-06-18

    Dietary Supplement ULTRA ARMOR Recalled for Undeclared Drug Ingredients

    ULTRA ARMOR dietary supplement, distributed by Health Fixer, is recalled nationwide because it contains undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.

    Product
    ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2025·2025-06-18

    Male Ultra Pro dietary supplement recalled for undeclared pharmaceutical ingredients

    Male Ultra Pro capsules are being recalled because laboratory testing found undeclared propoxyphenylsildenafil and sildenafil. The product was marketed without an approved New Drug Application.

    Product
    Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2025·2025-06-18

    Philips Intera 1.5T Explorer/Nova Dual MRI Gradient Coil Fire Risk

    Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.

    Product
    Intera 1.5T Explorer/Nova Dual Product Number: 781108;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2025·2025-06-18

    Femoral Nail T2 GTN Left and Right Versions Mislabeled

    Stryker GmbH is recalling certain Femoral Nail T2 GTN devices because some labeled as left version contained right nails, and vice versa. This mislabeling could result in incorrect surgical implantation.

    Product
    Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1957-2025·2025-06-18

    KWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up

    Microbiologics Inc is recalling KWIK-STICK quality control kits because products were packaged with incorrect microorganism swabs, which may lead to delayed diagnosis of patient samples in clinical laboratories.

    Product
    KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2025·2025-06-18

    Alaris Pump Infusion Sets may leak at male luer connections

    BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.

    Product
    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2025·2025-06-18

    Tecfen Medical 15 degree Stab Knife sterility assurance recall

    Tecfen Medical is recalling its 15 degree Stab Knife (Model QKN1501) due to sterility assurance concerns. The ophthalmic knife is used in eye surgeries and was distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2025·2025-06-18

    BD TEXIUM Closed Male Luer Drug Transfer Device Recall

    BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2025·2025-06-18

    iBOT PMD Personal Mobility Device Software Update Recall

    Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24 due to a software issue that could cause the device to tip over during Balance Mode operation.

    Product
    iBOT PMD with software version 01.05.24. Personal Mobility Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2025·2025-06-18

    Allon 2001 Medical Device Heating System Malfunction Risk

    Belmont Instrument's Allon 2001 device may heat water above safe limits if sensor connections fail and temperature alarms are disabled. The patient wrap may exceed its set temperature without user notification.

    Product
    Allon 2001. Part Number: 200-00263
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2025·2025-06-18

    Tecfen Medical 2.0mm Crescent Knife Ophthalmic Device Recall

    Tecfen Medical is recalling 2.0mm Crescent Knife ophthalmic surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. The affected devices were distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent kn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V418000·2025-06-18

    Mazda Recalls 2025 CX-50 Hybrid for Gear Shifter Safety Issue

    Mazda is recalling 2025 CX-50 Hybrid vehicles because the gear shifter can move to Drive without pressing the brake pedal, increasing crash risk.

    Product
    MAZDA — MAZDA CX-50 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25C008000·2025-06-18

    Evenflo Recalls Titan 65 Child Seats Due to Incorrect Instruction Manuals

    Evenflo is recalling Titan 65 child seats manufactured in early 2025 that may have incorrect instruction manuals, posing a risk of improper installation.

    Product
    EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2025·2025-06-18

    Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall

    Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.

    Product
    Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2025·2025-06-18

    Medical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination

    American Contract Systems, Inc. is recalling convenience kits containing cast padding due to elevated ethylene oxide and ethylene chlorohydrin residuals that may cause loss of functionality and delay treatment.

    Product
    LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2025·2025-06-18

    Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall

    Philips is recalling two Intera 1.5T MRI systems due to a gradient coil component failure that can produce smoke or fire, posing risks of inhalation injury, burns, asphyxia, or death.

    Product
    Intera 1.5T Master/Nova Product Number: 781106;
    Category
    Medical Device
    Distribution
    Distributed nationwide