State

Colorado product recalls

72,907 recalls have nationwide distribution and so reach Colorado. 6,941 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total: 6,941
Critical: 1,218
Severe: 1,507
Most recent: 2026-09-09

Of the 6,941 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 1,507 (22%) are Severe.

Which agencies issued them

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1351–1375 of 79848

HighFDA (Devices)·Z-2343-2026·2026-06-17
MIC Safety 24 Fr push PEG kits contain recalled lidocaine injection
MIC Safety PEG Kits, 24 Fr PUSH OTW, catalog number 7170-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 132 kits affected.
Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2335-2026·2026-06-17
CORFLO Safety PEG kit 30-6312 contains recalled lidocaine injection
CORFLO Safety PEG Kits, catalog number 30-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 31 kits are affected.
Product
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2312-2026·2026-06-17
Plum Duo infusion pumps may not display soft limit alerts
Plum Duo Infusion Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Product
Plum Duo Infusion Pump, 40002-0401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2409-2026·2026-06-17
Halyard drape packs shipped without undergoing validated sterilization process
Halyard Drape Packs, kit code LMDP36-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 72 kits affected.
Product
Halyard, Drape Pack. Kit Code: LMDP36-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2356-2026·2026-06-17
NexxZr dental zirconia discs may have reduced or missing dentin layer
NexxZr T Multi A3.5 zirconia discs for all-ceramic dental restorations are being recalled because a reduced or missing dentin layer increases the risk of fracture in the mouth.
Product
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2361-2026·2026-06-17
Medartis APTUS compression screws have off-centre cannulation in affected lots
Medartis APTUS 5.0 headed cannulated compression screws for bone fixation are being recalled because the cannulation of the screw is not centered. 13 units are affected.
Product
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2311-2026·2026-06-17
Plum Solo Precision IV pumps may not display soft limit alerts
Plum Solo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Product
Plum Solo Precision IV Pump, 40001-0401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2315-2026·2026-06-17
GE Allia IGS 5 Pulse systems pose shock risk to servicers
Allia IGS 5 Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. 121 units affected.
Product
Allia IGS 5 Pulse angiographic X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2339-2026·2026-06-17
CORFLO Safety PEG kit 50-6312 contains recalled lidocaine injection
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 43 kits affected.
Product
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2026·2026-06-17
MIC Safety 24 Fr pull ENFit PEG kits contain recalled lidocaine
MIC Safety PEG Kits with ENFit Connectors, 24 Fr PULL, catalog number 8180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2353-2026·2026-06-17
Natus SD LTM 64 PLUS EEG recorders may shift traces one second
SD LTM 64 PLUS EEG amplifier/recorders are being recalled because traces from different amplifiers in a multi-amplifier configuration may be displayed with a one-second shift.
Product
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2333-2026·2026-06-17
CORFLO Safety PEG kit 30-4320 contains recalled lidocaine injection
CORFLO Safety PEG Kits, catalog number 30-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 231 kits are affected.
Product
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2026·2026-06-17
TDC VELOCE 23 gauge vitrectomy cutters may have loose outer knife
TDC VELOCE 23G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
Product
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2325-2026·2026-06-17
CGuard Prime 8mm by 30mm carotid stents may fail deployment
CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Product
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2026·2026-06-17
MIC Safety 14 Fr pull PEG kits contain recalled lidocaine injection
MIC Safety PEG Kits, 14 Fr PULL, catalog number 7180-14, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 208 kits affected.
Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2362-2026·2026-06-17
EXENT Analyser marked plates as passed without performing quality control
An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.
Product
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2340-2026·2026-06-17
CORFLO Safety PEG kit 50-6316 contains recalled lidocaine injection
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6316, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 54 kits affected.
Product
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2342-2026·2026-06-17
MIC Safety 20 Fr push PEG kits contain recalled lidocaine injection
MIC Safety PEG Kits, 20 Fr PUSH OTW, catalog number 7170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 901 kits affected.
Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0607-2026·2026-06-17
Budesonide inhalation ampules contain black and brown specks and particles
Budesonide Inhalation Suspension, 1 mg/2 mL single-dose ampules from Sun Pharmaceutical, is being recalled after a quality complaint of black or brown specs and particles in the solution.
Product
BUDESONIDE — BUDESONIDE (BUDESONIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2400-2026·2026-06-17
Aluminum chloride hemostatic gel kits shipped with wrong package insert
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kits are being recalled because some units contain the package insert for Ferric Sulfate Gel, which gives different first aid instructions.
Product
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2026·2026-06-17
CGuard Prime 10mm by 40mm carotid stents may fail deployment
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Product
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2410-2026·2026-06-17
Halyard eye bag packs shipped without validated sterilization in Iowa
Halyard Eye Bag Packs, kit code UIEB48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 60 kits affected.
Product
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0583-2026·2026-06-17
Duloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
Duloxetine Delayed-Release Capsules, USP, 60 mg, are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit. 359,676 bottles affected.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2026·2026-06-17
MIC Safety 24 Fr pull PEG kits contain recalled lidocaine injection
MIC Safety PEG Kits, 24 Fr PULL, catalog number 7180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 1,006 kits affected.
Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2413-2026·2026-06-17
Orca single use endoscope valves recalled over sticking suction buttons
Boston Scientific is removing Orca Sterile, Single Use Air/Water and Suction Valves because of a higher than anticipated occurrence of the suction button sticking. 9,750 units affected.
Product
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
Category
Medical Device
Distribution
Distributed nationwide