State

Colorado product recalls

73,495 recalls have nationwide distribution and so reach Colorado. 6,947 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total: 6,947
Critical: 1,218
Severe: 1,823
Most recent: 2026-10-14

Of the 6,947 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 1,823 (26%) are Severe.

Which agencies issued them

These figures cover only the 6,947 recalls whose distribution notice names Colorado specifically. The 73,495 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

22201–22225 of 80442

HighFDA (Devices)·Z-1215-2022·2022-06-08
BD Anti-Kappa PE Flow Cytometry Reagent May Show Inaccurate Results
Becton Dickinson is recalling 199 units of BD Anti-Kappa PE flow cytometry reagent because samples may exhibit uncharacteristic flow profiles that could affect test accuracy.
Product
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2022·2022-06-08
FDA Recalls CVC Dressing Change Kit Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.
Product
CVC Dressing Change Kit Catalog Number: 2491R1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0966-2022·2022-06-08
Phenylephrine HCl Injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1169-2022·2022-06-08
Epidural Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
Product
Single Shot Epidural Tray Catalog Number: 6183R1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2022·2022-06-08
Surgical Instrument Seal Defect Recall: da Vinci Energy SynchroSeal
Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.
Product
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0953-2022·2022-06-08
Nephron Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.
Product
Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1175-2022·2022-06-08
Swab and Swabstick Drug Products Recalled for Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.
Product
Joint Injection Tray Catalog Number: 8561R1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1154-2022·2022-06-08
Swab and Swabstick Drug Products Recalled for Inadequate Manufacturing Validation
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled due to uncertainty regarding the adequacy of manufacturing test method validation.
Product
Universal Tray Catalog 1567
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0961-2022·2022-06-08
Injectable Labetalol HCl Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 115,640 units of Labetalol HCl Injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1205-2022·2022-06-08
Proton Therapy System Delivers Incorrect Radiation Dose in First Layer
The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.
Product
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0962-2022·2022-06-08
Lidocaine Injectable Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.
Product
Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0952-2022·2022-06-08
EPINEPHrine Pre-filled Syringes Recalled for Sterility Assurance Issue
Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.
Product
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0969-2022·2022-06-08
Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.
Product
Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2022·2022-06-08
Busse Nerve Block Tray Swabs Recalled for Test Method Validation Uncertainty
Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.
Product
Nerve Block Tray Catalog Number: 3764R2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2022·2022-06-08
Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings
Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.
Product
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Category
Medical Device
Distribution
24 states
HighFDA (Drugs)·D-0973-2022·2022-06-08
Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels
Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.
Product
LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V402000·2022-06-08
Keystone Coachworks Recalls 2020-2021 Mercedes Metris Vans for Gas Leak Risk
Keystone Coachworks is recalling 2020-2021 Mercedes-Benz Metris Custom Camper Vans because damaged burner control valves may cause a gas leak, increasing fire risk.
Product
KEYSTONE COACHWORKS — KEYSTONE COACHWORKS MERCEDES METRIS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0967-2022·2022-06-08
Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1170-2022·2022-06-08
Sterile Epidural Tray Recalled Due to Validation Uncertainty
Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.
Product
Sterile Epidural Tray Catalog Number: 6259R2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0955-2022·2022-06-08
Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2022·2022-06-08
Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue
Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.
Product
SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0965-2022·2022-06-08
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1158-2022·2022-06-08
Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.
Product
Nerve Block Tray Catalog Number: 8415
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2022·2022-06-08
Convenience Kits With Swab Drug Products Recalled for Test Validation Failure
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.
Product
Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1101-2022·2022-06-08
Keto Living Sugar Control Recalled: Undeclared Wheat in Gluten-Free Product
Natural Organics, Inc. is recalling 4,650 bottles of Keto Living Sugar Control nationwide and internationally due to undeclared wheat in a product labeled gluten-free. Consumers with wheat allergies or celiac disease should not use this product.
Product
Keto Living Sugar Control
Category
Food
Distribution
Distributed nationwide