State

Colorado product recalls

20,199 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.

9076–9100 of 20199

HighFDA (Devices)·Z-2117-2024·2024-05-29
GMAX SYR 10ML/LS Syringes Recalled for Non-Sterile Configuration and Regulatory Non-Compliance
Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.
Product
Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2024·2024-05-29
Fresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor
Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.
Product
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2098-2024·2024-05-29
Medline non-sterile syringes recalled for out-of-specification piston configurations
Medline non-sterile syringes (Model 91880) are being recalled because the piston sizes and configurations exceed what the manufacturer submitted for FDA approval. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2072-2024·2024-05-29
Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2097-2024·2024-05-29
Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope
Jiangsu Shenli Medical has recalled Medline non-sterile syringes because manufactured sizes and configurations exceed the FDA-cleared scope. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1846-2024·2024-05-29
Philips Ingenia MR Systems Recalled for Fire Risk From Loose Connector
Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.
Product
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1882-2024·2024-05-29
Cascade IOMAX Cortical Module recalled for potential electrical shock hazard
Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2024·2024-05-29
FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch
Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.
Product
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2024·2024-05-29
Philips MR System 1.5T Marlin MRI devices recalled due to fire hazard
Philips is recalling 10 MR System 1.5T Marlin MRI devices worldwide due to a fire and smoke hazard. A loose electrical connection in the mains distribution unit may create a hotspot that causes smoke or fire in hospital technical rooms.
Product
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2024·2024-05-29
Integra Cranial Access Kit Packaging Defects May Compromise Sterility
Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.
Product
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2110-2024·2024-05-29
GMAX Syringes Recalled for Manufacturing Outside FDA-Cleared Specifications
Jiangsu Shenli Medical Production recalled 37,200 GMAX non-sterile syringes manufactured outside FDA-approved specifications. Affected units were distributed across CA, FL, GA, IL, TN, and VA.
Product
Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2064-2024·2024-05-29
Non-Sterile Syringes Recalled Outside FDA-Cleared Size and Configuration Range
Medline is recalling 820,400 non-sterile syringes (model 91832) because their sizes and configurations fall outside what was cleared by the FDA. The devices were not manufactured within the approved specifications.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2049-2024·2024-05-29
Medline non-sterile syringes recalled for manufacturing outside FDA clearance scope
Medline non-sterile syringes (Model 83084) are being recalled because they were manufactured in sizes and configurations outside the scope of FDA clearance.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2088-2024·2024-05-29
Medline 20ML Non-Sterile Syringes Recalled for Non-Approved Configurations
Jiangsu Shenli Medical is recalling Medline 20ML non-sterile syringes (Model 91863) because certain piston syringe sizes and configurations were not cleared under the firm's FDA 510(k). The affected units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2044-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled for Configuration Exceeding FDA Clearance
Jiangsu Shenli Medical Production is recalling MEDLINE non-sterile syringes because certain configurations exceed the scope approved by the FDA. The recalled syringes were distributed nationwide across multiple states.
Product
Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2080-2024·2024-05-29
Medline Heparin Syringes Recalled for Exceeding FDA Approved Scope
Medline non-sterile syringes (Model 91851) are being recalled because their piston sizes and configurations exceed what the FDA approved. Approximately 7,000 units distributed in six states are affected.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2121-2024·2024-05-29
GMAX SYR 10ML Control Syringes Recalled for Exceeding Device Specifications
Jiangsu Shenli Medical Production is recalling GMAX SYR 10ML Control syringes because the device specifications exceed FDA-cleared limits. Approximately 348,800 units were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2083-2024·2024-05-29
Medline Syringes Recalled for Operating Outside FDA-Cleared Configurations
Jiangsu Shenli Medical is recalling 12,600 non-sterile syringes (Model 91855) distributed nationwide. The syringes operate in sizes and configurations not covered by the firm's FDA clearance.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2024·2024-05-29
Medline Syringes Recalled: Device Configuration Outside FDA Clearance Scope
Medline is recalling 10ML non-sterile syringes (Model 91857) distributed nationwide because the device configurations fall outside the FDA-cleared range for this product.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1889-2024·2024-05-29
Cerene Cryotherapy Device recall: missing error code in troubleshooting table
Channel Medsystems is recalling the Cerene Cryotherapy Device because error code 003 is missing from the device's troubleshooting documentation, which could prevent clinicians from properly diagnosing errors during use.
Product
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to r
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0504-2024·2024-05-29
Prescription Drug Sirolimus Recalled for Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling Sirolimus 1mg tablets nationwide due to failed impurity and degradation specifications. The recall affects 1,176 bottles from lot H2200493 expiring 6/30/2025.
Product
SIROLIMUS — SIROLIMUS (SIROLIMUS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Unapproved Configuration
Medline 10mL non-sterile syringes have been recalled because their piston size and configuration fall outside the range cleared by FDA. The recall affects 7,000 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2120-2024·2024-05-29
GMAX SYR 60ML/LS Syringes Recalled for Non-Approved Specifications
Jiangsu Shenli Medical is recalling GMAX SYR 60ML/LS syringes (Model TS2260S-M) because the piston syringe sizes and configurations exceed what was approved by FDA in the company's 510(k) clearance.
Product
Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2045-2024·2024-05-29
MEDLINE SYR 60ML Non-Sterile Syringes Recalled for Clearance Violation
Jiangsu Shenli Medical is recalling 1,117,800 MEDLINE SYR 60ML non-sterile syringes (Model 83080) because certain syringe sizes and configurations exceed what was approved under the manufacturer's FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide