The Recall Desk

State

Colorado product recalls

72,936 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.

Which agencies issued them

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3376–3400 of 79877

  • HighFDA (Devices)·Z-1303-2026·2026-02-11

    pTau 217 plasma calibrators recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 117 units of Lumipulse G pTau 217 Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2026·2026-02-11

    Electrosurgical knife KD-645 recalled over tip breakage during use

    Olympus is recalling 3,361 Single Use Electrosurgical Knife KD-645 units because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2026·2026-02-11

    Electrosurgical knives recalled over tip breakage from overheating and burning

    Olympus is recalling the Single Use Electrosurgical Knife KD-640L because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    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 electr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2026·2026-02-11

    Home male fertility tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Male Fertility Sperm Test for Home Use (Cassette)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2026·2026-02-11

    Exploro fertility tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0470-2026·2026-02-11

    Apple cinnamon sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Apple and Cinnamon flavour over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·26V079000·2026-02-11

    Western Star battery to starter stud may short circuit

    Daimler Trucks is recalling certain 2020-2027 Western Star 49X and 2021-2027 47X vehicles because a stud connecting the battery to the starter may be incorrectly installed or may corrode.

    Product
    WESTERN STAR — WESTERN STAR 47X, 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2026·2026-02-11

    Internal delivery devices recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2026·2026-02-11

    Surgical robots recalled over a software error hiding failed arm diagnostics

    Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.

    Product
    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:
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1267-2026·2026-02-11

    Vivoo sodium and hydration tests recalled over missing premarket clearance

    Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2026·2026-02-11

    Ketone and urinalysis strips recalled over missing premarket clearance

    Changchun Wancheng Bio-Electron is recalling 32,500 units covering The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2026·2026-02-11

    Typhoid antigen tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.

    Product
    S. Typhi/Para Typhi A Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V078000·2026-02-11

    Triumph motorcycle alternator wiring may short circuit and overheat

    Triumph is recalling certain 2022-2024 Bonneville, Street Twin, Street Scrambler, Speed Twin 900 and Scrambler 900 motorcycles because the wiring between the alternator and main harness connector may short circuit.

    Product
    TRIUMPH — TRIUMPH SCRAMBLER 900, STREET SCRAMBLER, STREET SCRAMBLER SANDSTOR, BONNEVILLE T100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0476-2026·2026-02-11

    Mango pineapple sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Mango and Pineapple variety over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango and Pineapple- UPC# 5065006235301
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2026·2026-02-11

    Subretinal injection cannulas recalled over voids in pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    25GA Subretinal Injection Cannula VS0220.25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2026·2026-02-11

    Amyloid 1-42-N plasma cartridges recalled over falsely elevated results

    Fujirebio Diagnostics is recalling 1,423 units of Lumipulse G beta-Amyloid 1-42-N Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0305-2026·2026-02-11

    Trazodone tablets recalled over the presence of foreign tablets

    Granules Pharmaceuticals is recalling 71,424 bottles of Trazodone Hydrochloride, USP 50 mg, over the presence of foreign tablets or capsules.

    Product
    TRAZODONE HYDROCHLORIDE — TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2026·2026-02-11

    Retractable membrane polishers recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Tecfen Retractable Membrane Polisher, QTPR1267-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2026·2026-02-11

    pTau 217 plasma cartridges recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0473-2026·2026-02-11

    Blue spirulina raspberry sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Blue Spirulina and Raspberry variety over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Blue Spirulina and Raspberry- UPC# 5065006235813
    Category
    Food
    Distribution
    Distributed nationwide