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.

14576–14600 of 20364

HighFDA (Drugs)·D-0107-2023·2023-01-18
Injectable Drug Recall: QuadMix Standard 001 Lacks Sterility Assurance
Northern VA Compounders recalls QuadMix Standard 001 injectable vials due to lack of sterility assurance. No illnesses reported.
Product
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/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-0910-2023·2023-01-18
Source Administration Set medical device recalled for contamination
The FDA has recalled 2,840 units of the Source Administration Set, a medical device used for PET imaging, due to contamination with black specks on needles.
Product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commo
Category
Medical Device
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-0934-2023·2023-01-18
Henry Shein Sterile Gloves Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.
Product
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case;
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-0931-2023·2023-01-18
Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.
Product
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0111-2023·2023-01-18
FDA Recalls Prostaglandin E1 Injection for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution due to lack of sterility assurance. The recall affects 108 vials distributed nationwide.
Product
Prostaglandin (E1) Injection Solution, 25mcg/ml, 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-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 (Drugs)·D-0112-2023·2023-01-18
Prostaglandin E1 Injection Vials Recalled for Sterility Issues
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution vials nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider.
Product
Prostaglandin (E1) Injection Solution, 40mcg/ml, 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-0919-2023·2023-01-18
Anspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
The Anspach Adult Rotating Craniotome Attachment (CRANI-A-R) may have ball bearings that detach during surgical use. The FDA recommends users follow inspection intervals to prevent potential serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0119-2023·2023-01-18
Methylcobalamin Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling Methylcobalamin Injection Solution (12.5mg/ml, 2 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 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-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-0100-2023·2023-01-18
Prescription Rifampin Capsules Recalled for Failed Impurity Specifications
Lupin Pharmaceuticals is recalling Rifampin Capsules (300 mg) nationwide due to failed impurity and degradation specifications found during stability testing. Lot A200171 (exp. 12/2023) is affected, with over 16,000 bottles distributed.
Product
RIFAMPIN — RIFAMPIN (RIFAMPIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2023·2023-01-18
Medical device software bug may cause patient sample order mismatches in rare cases
A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.
Product
cobas infinity central lab, Material Number 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2023·2023-01-18
Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal
Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.
Product
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
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 (Devices)·Z-0916-2023·2023-01-18
Craniotome Attachment Ball Bearings May Detach During Surgery
The Anspach 6.5 cm Adult Rotating Craniotome Attachment may have ball bearings that detach during surgical use or removal. The manufacturer recommends following inspection intervals to prevent serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
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 (Drugs)·D-0104-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling QuadMix Standard 002 injectable medication because sterility of one lot cannot be assured. The recall affects 12 vials distributed nationwide.
Product
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/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-0124-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/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 (Drugs)·D-0123-2023·2023-01-18
TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/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 (Food)·F-0253-2023·2023-01-18
Sanders Dark Chocolate Maple Sea Salt Caramel Recalled for Foreign Material
Sanders Candy LLC is recalling Sanders Dark Chocolate Maple Sea Salt Caramel due to brush bristles found in the product. Consumers should not consume affected units.
Product
Sanders Dark Chocolate Maple Sea Salt Caramel: No UPC 6oz. foil bag
Category
Food
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-0251-2023·2023-01-18
Sanders Milk Chocolate Sea Salt Pecan Cluster Recalled for Brush Bristles
Sanders Candy LLC recalls Sanders Milk Chocolate Sea Salt Pecan Cluster due to foreign material—pieces of cleaning brush bristles—found in the product. The recall affects nearly 1 million units distributed nationwide and in Canada.
Product
Sanders Milk Chocolate Sea Salt Pecan Cluster: 0-35900-25550-2 .5OZ Individual Wrapped 0-35900-27486-2 25OZ Tub 0-35900-30971-7 18OZ Tub 0-35900-30170-4 7OZ Pouch
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2023·2023-01-18
Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide