The Recall Desk

State

Colorado product recalls

20,199 recalls have nationwide distribution and so reach Colorado. 0 additional recalls listed Colorado specifically in their distribution scope.

About recalls in Colorado

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Colorado consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

9701–9725 of 20199

  • HighNHTSA·23V169000·2024-04-03

    Keystone Cougar travel trailers recalled for missing emergency exit window

    Keystone is recalling certain 2022-2023 Cougar travel trailers that may lack a required emergency exit window, creating a safety hazard in emergency situations. Owners should contact Keystone customer service for a free inspection and replacement if needed.

    Product
    KEYSTONE — 2022 KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2024·2024-04-03

    Thermalon Stye Compress recalled due to potential mold and mildew

    Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.

    Product
    Thermalon Stye Compress, Item Number 24352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0413-2024·2024-04-03

    Neostigmine methylsulfate injection recalled nationwide due to sterility concerns

    SCA Pharmaceuticals is recalling 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).

    Product
    neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0395-2024·2024-04-03

    Fentanyl Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls fentanyl 2,500 mcg/250 mL injection (548 bags) nationwide due to lack of assurance of sterility. The affected product may not meet pharmaceutical sterility standards required for injectable drugs.

    Product
    fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2024·2024-04-03

    Medivance Neonatal ArcticGel Pads Recalled for Reduced Water Flow

    Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.

    Product
    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2024·2024-04-03

    Laboratory performance verifier recalled for mismatched diluent assembly

    Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.

    Product
    VITROS Performance Verifier I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V197000·2024-04-03

    2022 Hyundai Santa Fe and Santa Cruz Turbocharger Oil Pipe Fire Risk Recall

    Hyundai is recalling 2022 Santa Fe and Santa Cruz vehicles because the turbocharger oil supply pipe may crack, causing an oil leak that could increase fire risk in the engine compartment.

    Product
    HYUNDAI — 2022 HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2024·2024-04-03

    Epix Universal Clip Applier Recalled for Potential Clip Loading Failure

    Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.

    Product
    Epix Universal Clip Applier, REF: CA500, STERILEEO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2024·2024-04-03

    Cystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias

    Randox Laboratories is recalling Cystatin C Calibrator Series CVS 2699 because it runs with negative bias compared to other methods, which could affect test accuracy on automated analyzers.

    Product
    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0404-2024·2024-04-03

    FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns

    SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.

    Product
    HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2024·2024-04-03

    Aptima CMV Quant Assay Recalled for Invalid Results with Plasma Specimens

    Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.

    Product
    Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Recons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2024·2024-04-03

    Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak

    Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.

    Product
    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2024·2024-04-03

    RELAY PRO Thoracic Stent-Graft System recalled for incorrect size

    Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.

    Product
    RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0408-2024·2024-04-03

    HYDROmorphone Injectable Recalled Due to Sterility Assurance Failure

    SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.

    Product
    HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0419-2024·2024-04-03

    Pharmaceutical Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling PHENYLephrine HCl 40 mg injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider and not use this product.

    Product
    PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0415-2024·2024-04-03

    Phenylephrine Injectable Drug Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.

    Product
    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0406-2024·2024-04-03

    HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues

    SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were distributed nationwide.

    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0410-2024·2024-04-03

    Hydromorphone Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0411-2024·2024-04-03

    Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.

    Product
    labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0416-2024·2024-04-03

    PHENYLephrine Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.

    Product
    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID fo
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0428-2024·2024-04-03

    Oral Contraceptive Tablets Recalled for Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling TRI-LO-SPRINTEC oral contraceptive tablets nationwide due to failed dissolution specifications affecting 92,676 cartons.

    Product
    TRI-LO-SPRINTEC — TRI-LO-SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1376-2024·2024-04-03

    Access Substrate Reagent Bottles Recalled for Missing Product Labels

    Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.

    Product
    Access Substrate, REF 81906, For use with the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2024·2024-04-03

    Thermalon Heating Pads Recalled for Potential Mold and Mildew Growth

    Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.

    Product
    Thermalon Heating Pad, Item Number 24002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0427-2024·2024-04-03

    FDA Recalls VCF Contraceptive Film Due to Manufacturing Process Violations

    The FDA is recalling VCF Contraceptive Film due to manufacturing process deviations. Apothecus Pharmaceutical Corp. initiated the voluntary recall on March 21, 2024, affecting 17,280 cartons distributed nationwide.

    Product
    VCF CONTRACEPTIVE — VCF CONTRACEPTIVE (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2024·2024-04-03

    Thermalon Neck Wrap recalled due to potential mold and mildew growth

    Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.

    Product
    Thermalon Neck Wrap, Item Number 24322
    Category
    Medical Device
    Distribution
    Distributed nationwide