State

Colorado product recalls

73,104 recalls have nationwide distribution and so reach Colorado. 6,945 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total: 6,945
Critical: 1,218
Severe: 1,510
Most recent: 2026-10-02

Of the 6,945 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 1,510 (22%) are Severe.

Which agencies issued them

These figures cover only the 6,945 recalls whose distribution notice names Colorado specifically. The 73,104 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9651–9675 of 80049

HighFDA (Devices)·Z-0161-2025·2024-10-30
Medline medical procedure kits recalled for potential sterility breach
Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.
Product
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF…
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-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-0180-2025·2024-10-30
Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
Product
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2025·2024-10-30
Medline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised
Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.
Product
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
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.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Potential Non-Sterility Risk
Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.
Product
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7)…
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-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-0160-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF…
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 (Drugs)·D-0024-2025·2024-10-30
Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen
AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.
Product
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2025·2024-10-30
Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation
Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.
Product
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0058-2025·2024-10-30
Juice Recall: Incomplete Pasteurization in Happy Moose Tropical Roots
Happy Moose Juice Tropical Roots is recalled due to incomplete pasteurization of certain bottles. Consumers should not consume products with lot number H240903-E and enjoy-by date 12/02/2024.
Product
Happy Moose Juice Tropical Roots packaged in a plastic 12 fl. oz. bottle. Ingredients: Mandarin Orange, Organic Carrot Juice, Organic Pineapple Juice, Lemon Juice, and Organic Turmeric Juice. UPC 860012096503
Category
Food
Distribution
39 states
HighFDA (Devices)·Z-0163-2025·2024-10-30
Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk
Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Product
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0017-2025·2024-10-30
Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations
Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2025·2024-10-30
Medline catheter procedure kits recalled for potential sterility compromise
Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.
Product
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S…
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…
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-0176-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
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-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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0077-2025·2024-10-30
Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk
Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.
Product
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide