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.

9101–9125 of 20199

ModerateFDA (Devices)·Z-2047-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Exceeding FDA-Cleared Specifications
Jiangsu Shenli Medical is recalling about 38.8 million Medline SYR 10ML L/L non-sterile syringes (Model 83082) because their sizes and configurations exceed FDA-cleared specifications. Nationwide distribution in CA, FL, GA, IL, TN, and VA.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2087-2024·2024-05-29
MEDLINE 5ML Non-Sterile Syringes Recalled for Unapproved Configurations
MEDLINE non-sterile syringes (Model 91859) are being recalled because their sizes and configurations exceed the scope of the manufacturer's FDA 510(k) clearance. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 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 (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-2103-2024·2024-05-29
Wolf Medical Syringes Recalled for Uncleared Size and Configuration Variants
Jiangsu Shenli Medical is recalling Wolf Medical 6 mL syringes because certain variants weren't cleared under the 510(k). Approximately 454,400 units distributed nationwide are affected.
Product
Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR06L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2122-2024·2024-05-29
GMAX Blue Syringes Recalled for Out-of-Range Design Configurations
Jiangsu Shenli Medical recalled 9,800 GMAX blue syringes because their sizes and configurations fall outside FDA's clearance range. Affected units were distributed nationwide to healthcare facilities and retailers.
Product
Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2057-2024·2024-05-29
Non-sterile syringes recalled for configurations exceeding FDA clearance
Medline is recalling approximately 95,200 non-sterile 5mL syringes (Model 91825) distributed nationwide because syringe sizes and configurations exceed the scope of FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2066-2024·2024-05-29
Non-sterile Syringes Recalled for Unapproved Specifications
Jiangsu Shenli Medical Production is recalling approximately 749,400 non-sterile syringes (10ml) distributed under the Medline brand because their sizes and configurations were not cleared by FDA.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2063-2024·2024-05-29
FDA Recalls Medline Non-Sterile Syringes for Regulatory Non-Compliance
Medline has recalled approximately 325,500 non-sterile syringes (Model 91831) due to syringe sizes and configurations that fall outside FDA-cleared specifications. The syringes were distributed nationwide and manufactured by Jiangsu Shenli Medical Production Co., Ltd.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 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-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-2075-2024·2024-05-29
Medline 20mL Non-Sterile Syringes Recalled for Configuration Non-Conformance
Medline syringes (Model 91845) distributed across six US states are recalled because their piston configurations don't match FDA-cleared design specifications. The recall affects approximately 40,800 units.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2128-2024·2024-05-29
MEDLINE 20ML Non-Sterile Syringes Recalled for Configurations Outside FDA Clearance
MEDLINE non-sterile syringes (Model 91843) are being recalled because the product's sizes and configurations fall outside the scope of devices approved under the manufacturer's FDA 510(k) submission. The syringes were distributed nationwide across multiple U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 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-2079-2024·2024-05-29
Medline 10ml Syringes Recalled for Exceeding FDA Clearance Range
Jiangsu Shenli Medical is recalling 39,200 Medline non-sterile syringes (Model 91850) because the device sizes and configurations exceed the range approved by the FDA's 510(k) clearance. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2073-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Range Sizes and Configurations
Medline non-sterile syringes (Model 91841) are recalled because certain size and configuration variants were not included in the FDA-cleared 510(k) specifications. These uncleared configurations should not have been distributed.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2065-2024·2024-05-29
Medline non-sterile syringes recalled for unauthorized syringe sizes and configurations
Medline non-sterile syringes (Model 91833) are being recalled because the manufactured syringe sizes and configurations do not match the company's regulatory clearance. Consumers should stop using the recalled lot numbers.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2111-2024·2024-05-29
FDA Recalls GMAX Non-Sterile 10ML Syringes Due to Non-Compliant Manufacturing Specifications
GMAX non-sterile syringes are being recalled because their actual sizes and configurations exceed the range of specifications the manufacturer obtained FDA clearance for.
Product
Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2089-2024·2024-05-29
FDA Recalls Medline Syringes Manufactured Outside Approved Specifications
Jiangsu Shenli Medical Production Co. is recalling 9,800 Medline non-sterile syringes (Model 91866, Lot 63722070002) because the devices were manufactured in sizes and configurations outside the firm's FDA-cleared scope.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2071-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Unapproved Device Configurations
Jiangsu Shenli Medical is recalling 178,400 non-sterile syringes sold under the Medline brand because the device configurations exceed what was cleared under the firm's FDA 510(k) application.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
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-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-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 (Devices)·Z-2102-2024·2024-05-29
Wolf Medical 3 mL Syringes Recalled for Out-of-Specification Manufacturing
Jiangsu Shenli Medical is recalling 777,400 Wolf Medical 3 mL syringes (Model SYR03L) manufactured outside FDA clearance scope. Users should discontinue use of affected lot codes.
Product
Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2115-2024·2024-05-29
GMAX SYR 35ML Non-Sterile Syringes Recalled for Regulatory Non-Compliance
The FDA is recalling GMAX SYR 35ML/LL non-sterile syringes because the device specifications exceed what the manufacturer had FDA clearance to produce. No illnesses have been reported.
Product
Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide