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.

6701–6725 of 79925

  • HighFDA (Devices)·Z-1872-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter recalled for sterility defect

    Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.

    Product
    Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2025·2025-06-04

    ELEOS Male-Female Midsection 40MM Orthopedic Component Recall

    Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.

    Product
    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Triple Lumen Recall

    Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2025·2025-06-04

    Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion

    Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect

    Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2025·2025-06-04

    Abbott Diagnostics Vitamin D Calibrator Transit Storage Conditions Issue

    The Abbott Diagnostics Architect Vitamin D 6-Level Calibrator was exposed to improper storage conditions during transit due to severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.

    Product
    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2025·2025-06-04

    Cholestech LDX Lipid Profile and Glucose Test Kits Recalled

    McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2025·2025-06-04

    Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure

    Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2025·2025-06-04

    Abbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure

    McKesson Medical-Surgical is recalling Abbott Point of Care Test Creatinine I-STAT cartridges distributed nationwide after transit delays during severe thunderstorms caused improper storage conditions, increasing the risk of incorrect or delayed test results.

    Product
    ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1832-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS Phosphorus Reagent Recall

    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS reagent units may have been stored outside recommended cold chain conditions due to severe thunderstorms, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2025·2025-06-04

    GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm

    Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2025·2025-06-04

    VITROS Chemistry Products CRP Slides Incorrectly Labeled Coating Generation

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because the product carton, foil wrapper, and cartridge label were incorrectly marked with "GEN 88" instead of the correct "GEN 83" designation.

    Product
    VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1859-2025·2025-06-04

    Ultrasonic Cleaning Systems Triton 36 and 72 recalled

    Ultra Clean Systems, Inc. is recalling Ultrasonic Cleaning Systems Triton 36 and Triton 72 models due to carbon filter sensors breaking down from electrochemical degradation. The defect was identified during routine preventative maintenance checks.

    Product
    Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1861-2025·2025-06-04

    Straumann Plus Initial Drill missing laser engraving marking

    Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the required 7 mm laser engraving marking.

    Product
    Plus Initial Drill, Article Number: 103.170;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1831-2025·2025-06-04

    Ortho Clinical Diagnostics Vitros Calcium Reagent Recalled Due to Storage Conditions

    Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent is being recalled because transit delays caused by severe thunderstorms may have stored products outside recommended cold chain conditions, potentially leading to incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2025·2025-06-04

    Abbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion

    Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2025·2025-06-04

    Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue

    Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator units experienced transit delays due to severe thunderstorms, potentially exposing products to storage conditions outside the manufacturer's recommendations. This may increase the risk of incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2025·2025-06-04

    Abbott Diagnostics Alinity I Free PSA Reagent Affected by Storage Conditions

    Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.

    Product
    ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2025·2025-06-04

    HemoCue HemoTrol High Control Product Recalled Due to Storage Conditions

    HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2025·2025-06-04

    Abbott Diagnostics Probe Conditioning Solution Recall

    Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2025·2025-06-04

    Abbott Diagnostics Architect Progesterone Reagent Storage Condition Recall

    Abbott Diagnostics Architect Progesterone (100 tests) reagent is being recalled due to transit delays during severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2025·2025-06-04

    Glidewell HT Implant Twist Drill recalled due to packaging mix-up

    Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm devices due to a packaging mix-up that resulted in incorrect finished devices being placed in packages.

    Product
    Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0447-2025·2025-06-04

    Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications

    Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.

    Product
    BROMFENAC OPHTHALMIC SOLUTION 0.09% — BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1825-2025·2025-06-04

    Abbott Rapid DX Cholestec LDX Lipid Profile Test Cassettes Recall

    Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
    Category
    Medical Device
    Distribution
    Distributed nationwide