State

Colorado product recalls

20,188 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.

7276–7300 of 20188

HighFDA (Devices)·Z-0173-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk
Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0020-2025·2024-10-30
FDA Recalls NORepinephrine Injection Due to Manufacturing Violations
Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.
Product
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0079-2025·2024-10-30
Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet
Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.
Product
Amingo. OUS only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0179-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Product
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0134-2025·2024-10-30
Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error
Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.
Product
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0022-2025·2024-10-30
FDA recalls epinephrine injection for manufacturing compliance violations
Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.
Product
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0223-2025·2024-10-30
A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes
Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.
Product
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0133-2025·2024-10-30
Medline Recalls Centurion CirClamp Sterile Surgical Devices for Packaging Defects
Medline Industries is recalling 498,354 units of Centurion CirClamp sterile surgical clamps due to holes in the packaging that may compromise sterility assurance. No illnesses or injuries have been reported.
Product
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2025·2024-10-30
Ultrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Product
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2025·2024-10-30
Medline convenience kits recalled for potential use of non-sterile product
Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.
Product
Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2025·2024-10-30
Medline Centurion Tracheostomy Kit Recalled Due to Non-Sterility Risk
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Product
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0153-2025·2024-10-30
Medline Procedure Kits Recalled for Non-Sterile Product Risk
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2025·2024-10-30
SynchroMed II Infusion Pump Recalled Due to Memory Data Corruption
Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.
Product
SynchroMed II Infusion Pump. Product Number: 8637-20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0221-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error
Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0220-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy
Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0162-2025·2024-10-30
Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging
Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.
Product
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2025·2024-10-30
Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk
Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2025·2024-10-30
Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise
Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.
Product
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging defect
Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2025·2024-10-30
Internal Defibrillation Paddles Recalled for Cracks and Separation
Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.
Product
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2025·2024-10-30
Shimadzu Trinias Unity Catheterization Table Movement Control Defect
Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.
Product
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0154-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue
Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.
Product
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2025·2024-10-30
Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Product
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0165-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.
Product
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
Category
Medical Device
Distribution
Distributed nationwide