The Recall Desk

State

Colorado product recalls

20,364 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.

14601–14625 of 20364

  • HighFDA (Devices)·Z-0939-2023·2023-01-18

    HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks

    Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.

    Product
    HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2023·2023-01-18

    Adult Craniotome Bearings May Detach During Surgical Use

    Ball bearings in the Anspach Adult Craniotome attachment may detach during removal or during surgery. Failure to follow recommended inspection intervals increases the risk of serious patient injury.

    Product
    Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0114-2023·2023-01-18

    TriMix Injection Recalled Due to Sterility Assurance Failure

    Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2023·2023-01-18

    VENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results

    Ventana Medical Systems recalled 8,927 VENTANA PD-L1 (SP142) Assay kits worldwide due to light staining that can cause false-negative immunotherapy marker test results affecting cancer treatment decisions.

    Product
    VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2023·2023-01-18

    Central Line Insertion Trays Recalled for Potential Sterility Breaches

    Stradis Healthcare is recalling HCT Central Line Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. Approximately 1,176 units were distributed nationwide.

    Product
    HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2023·2023-01-18

    Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise

    Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.

    Product
    Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2023·2023-01-18

    Stradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach

    Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.

    Product
    Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2023·2023-01-18

    IMMULITE 2000 Thyroglobulin test kits recalled for reduced analytical sensitivity

    Siemens is recalling 717 IMMULITE 2000 Thyroglobulin test kits because they may not accurately measure thyroglobulin levels. Inaccurate results could affect monitoring of thyroid cancer patients.

    Product
    IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2023·2023-01-18

    BD Pyxis MedBank System may dispense wrong medication due to software error

    The BD Pyxis MedBank medication dispensing system has a software error that may cause the wrong medication to be loaded in a drawer compared to what the label shows, risking patient harm.

    Product
    BD Pyxis MedBank System - Product Label/labeling pending
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2023·2023-01-18

    Injectable drug recalled due to lack of sterility assurance

    Northern VA Compounders PLLC recalls compounded injectable QuadMix Super 001 (56 vials) nationwide due to lack of assurance of sterility. Affected lot #11162022@7, expiration 12/31/2022.

    Product
    QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2023·2023-01-18

    Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks

    Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.

    Product
    HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2023·2023-01-18

    Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk

    Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.

    Product
    HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0250-2023·2023-01-18

    Sanders Milk Chocolate Sea Salt Caramels Recalled for Foreign Material

    Sanders Candy LLC is recalling Sanders Milk Chocolate Sea Salt Caramels due to potential cleaning brush bristles contamination. The product poses a choking and injury hazard.

    Product
    Sanders Milk Chocolate Sea Salt Caramels: UPC 0-35900-27636-1 36OZ Tub UPC 0-35900-25551-9 .5OZ Individual Wrapped UPC 0-35900-27436-7 28OZ Tub UPC 0-35900-27636-1 2 pack 36OZ Tub UPC 0-35900-30781-2 6OZ Pouch UPC 0-35900-30970-0 18OZ Tub UPC 0-35900-30986-1 18OZ Tub UPC 0-35900
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2023·2023-01-18

    Neonatal PICC Tray Recalled Due to Potential Sterility Breach

    Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.

    Product
    Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2023·2023-01-18

    Pediatric Craniotome Recalled for Ball Bearing Detachment Risk

    The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing serious patient injury.

    Product
    Pediatric Craniotome Ref:CRANI-P-G1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2023·2023-01-18

    Compounded Injectable Drug Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders has recalled QuadMix Super 002 injectable medication due to lack of assurance of sterility. The affected lot is distributed nationwide.

    Product
    QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2023·2023-01-18

    Surgical Craniotome Attachment Ball Bearings Have Detached During Surgery

    The Anspach 7.5 cm Large Rotating Craniotome Attachment ball bearings have come out during surgery or device removal. Failure to follow proper inspection intervals may result in serious patient injury.

    Product
    7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2023·2023-01-18

    FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels

    DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.

    Product
    BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0115-2023·2023-01-18

    TriMix Injectable Medication Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection due to lack of sterility assurance. The injectable was distributed nationwide; affected patients should not use these vials and should contact their healthcare provider.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2023·2023-01-18

    HCT 500mL Sterile Medical Bags Recalled for Potential Pinhole Leaks

    Stradis Healthcare is recalling HCT 500mL sterile medical bags due to potential pinhole leaks near the seal that could compromise sterility. The recall affects 644 units distributed across nine U.S. states.

    Product
    HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0249-2023·2023-01-18

    Sanders Assorted Milk and Dark Sea Salt Caramels recalled for brush bristle contamination

    Sanders Candy LLC is recalling Sanders Assorted Milk and Dark Sea Salt Caramels nationwide and in Canada due to cleaning brush bristles found in the product. Consumers should not eat affected candy and should return it to the retailer.

    Product
    Sanders Assorted Milk and Dark Sea Salt Caramels UPC 0-35900-31080-5 7oz Gift Box UPC 0-35900-29782-3 .5OZ Silver Box UPC 0-35900-29793-9 7OZ Silver Box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2023·2023-01-18

    Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging

    International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.

    Product
    Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2023·2023-01-18

    Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery

    Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.

    Product
    7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0122-2023·2023-01-18

    BiMix Injection Recalled for Lack of Assurance of Sterility

    Northern VA Compounders has recalled BiMix Injection due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0116-2023·2023-01-18

    TriMix Injection Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders is recalling TriMix Injection due to lack of sterility assurance. The compounded injectable medication may not meet required sterility standards.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide