State

Colorado product recalls

20,371 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.

15276–15300 of 20371

HighFDA (Devices)·Z-0102-2023·2022-10-26
ARROW Midline Catheter Kit Mislabeled with Wrong Device Type
ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.
Product
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0090-2023·2022-10-26
ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk
B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.
Product
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0092-2023·2022-10-26
IV extension set recall for potential joint failure and leakage risk
B. Braun is recalling CARESITE SMALLBORE EXT SET T-PORT 5 IN. devices due to potential bonded joint failure that could cause leakage or detachment during use. The malfunction may result in delayed therapy, bloodstream infection risk, and exposure to hazardous medications.
Product
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0013-2023·2022-10-26
Acyclovir Sodium Injectable Recalled for Particulate Matter
AuroMedics Pharma is recalling Acyclovir Sodium injection due to dark red, brown, and black particulate matter found in vials. Approximately 89,400 vials were distributed nationwide.
Product
ACYCLOVIR SODIUM — ACYCLOVIR SODIUM (ACYCLOVIR SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0104-2023·2022-10-26
Lithium diagnostic assay may display falsely elevated results on Atellica CH analyzer
The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.
Product
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0043-2023·2022-10-26
Market Pantry White Fudge Animal Cookies Recalled for Metal Contamination
Market Pantry White Fudge Animal Cookies sold at Target may contain metal fragments. D. F. Stauffer Biscuit Co is recalling 883 cases distributed nationwide.
Product
White frosted animal cookies with multi-colored non-pareils in a 44oz plastic jug labeled "Market Pantry White Fudge Animal Cookies"
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0113-2023·2022-10-26
Reusable Oral Syringe Recalled for Unapproved Plunger Material
Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.
Product
Medicina Reusable Oral syringe 5ml Code: OTH05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2023·2022-10-26
MitraClip Clip Delivery System Recalled for Locking Malfunctions
Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.
Product
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0110-2023·2022-10-26
Oral Tip Syringes Recalled Due to Unapproved Plunger Material
Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.
Product
Medicina Oral Tip Syringe 1ml Code: OT01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0109-2023·2022-10-26
Medicina Oral Tip Syringe Recall Due to Unapproved Plunger Material
Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The syringes do not meet raw material specifications.
Product
Medicina Oral Tip Syringe 0.5ml Code: OT005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0107-2023·2022-10-26
Medicina ENFit enteral syringe recall due to material specification defect
Medicina is recalling ENFit 1ml enteral syringes because the plunger was manufactured with polyethylene instead of approved polypropylene. This material defect could affect plunger function and device safety.
Product
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0106-2023·2022-10-26
Chest Tube Insertion Tray Recalled Due to Over-Sterilization of Suture Component
Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.
Product
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0100-2023·2022-10-26
Synthes SPEED implant recall: drill guide size mismatch in surgical kit
Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.
Product
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0089-2023·2022-10-26
Dimension Vista HDLC Reagent Cartridge Recalled for Inaccurate Lab Results
Siemens is recalling 1,592 units of Dimension Vista HDLC reagent cartridges due to potential for erroneous test results. Affected cartridges may produce falsely high or low HDL cholesterol measurements.
Product
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0111-2023·2022-10-26
Medicina Oral Tip Syringe recalled for unapproved plunger material
Medicina Uk Ltd is recalling Medicina Oral Tip Syringe 2.5ml nationwide because the plunger component was manufactured with polyethylene instead of the approved polypropylene material.
Product
Medicina Oral Tip Syringe 2.5ml Code: OT25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0101-2023·2022-10-26
DePuy Synthes Hammertoe Implants Recalled for Incorrect Drill Guide Size
Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.
Product
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0093-2023·2022-10-26
Siemens N Antiserum to Human IgG Recall for High-Dose Performance Failure
Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.
Product
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2023·2022-10-26
IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk
B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.
Product
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0015-2023·2022-10-26
Saline Solution Injection Recalled Nationwide Due to Sterility and Leakage
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection distributed nationwide due to lack of assurance of sterility and potential leakage. Multiple lot numbers with expiration dates ranging from May 2023 to August 2023 are affected.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0011-2023·2022-10-26
Rifampin Capsules recalled due to excessive impurity levels
Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 300 mg, because samples exceeded acceptable limits for 1-Methyl-4-Nitrosopoperazine (MNP), an impurity. Multiple lot numbers were distributed nationwide.
Product
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0105-2023·2022-10-26
Medical device assay may report falsely elevated lithium levels
Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.
Product
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0095-2023·2022-10-26
BD Vacutainer Blood Alcohol Testing Tubes Recalled for Analytical Interference
BD Vacutainer blood collection tubes are recalled due to isobutylene contamination that may cause false positive results in blood alcohol testing.
Product
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0112-2023·2022-10-26
Medicina Reusable Oral Syringe Recalled for Unapproved Plunger Material
Medicina Uk Ltd is recalling Medicina Reusable Oral syringes because the plunger was manufactured with polyethylene instead of the required polypropylene material. The 11,100 affected syringes do not meet raw material specifications.
Product
Medicina Reusable Oral syringe 1ml Code: OTH01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0094-2023·2022-10-26
N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards
Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.
Product
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0116-2023·2022-10-26
Abbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk
Abbott is recalling MitraClip and TriClip Clip Delivery Systems due to clip locking malfunctions. Failed procedures may result in mitral regurgitation recurrence, device embolization, or tissue injury.
Product
Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, Mi
Category
Medical Device
Distribution
Distributed nationwide