State

Hawaii product recalls

20,304 recalls have nationwide distribution and so reach Hawaii. 0 additional recalls listed Hawaii specifically in their distribution scope.

About recalls in Hawaii

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 Hawaii 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.

9151–9175 of 20304

HighFDA (Devices)·Z-2048-2024·2024-05-29
Non-sterile Piston Syringes Distributed Outside FDA-Approved Specifications
Medline piston syringes (Model 83083) manufactured by Jiangsu Shenli are being recalled because their sizes and configurations fall outside FDA-approved specifications. Approximately 494,000 units are affected across the United States.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2024·2024-05-29
Medline 5ML Heparin Syringes Recalled for Specification Non-Compliance
Medline 5ML heparin syringes (Model 91867) are being recalled because the syringe sizes and configurations do not match the range of products approved by the FDA. No injuries or illnesses have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1851-2024·2024-05-29
Philips Ingenia Ambition X MR systems recalled for loose terminal connection fire hazard
Philips is recalling 509 Ingenia Ambition X MR systems due to loose terminal connections in the g-MDU L3 unit that may create hotspots and cause smoke or fire in hospital technical rooms.
Product
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2024·2024-05-29
GMAX Non-Sterile Syringes Recalled for Unapproved Sizes and Configurations
GMAX non-sterile syringes in various sizes and configurations have been recalled because they fall outside the FDA 510(k) scope of the manufacturer's clearance. Affected lots were distributed across six U.S. states.
Product
Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1850-2024·2024-05-29
Philips Ingenia Ambition S MRI systems recalled for potential fire hazard
Philips is recalling Ingenia Ambition S MRI systems due to a potential fire hazard. A loose terminal connection in the electrical distribution unit may create a hotspot and smoke or fire in hospital technical rooms.
Product
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2024·2024-05-29
Merit Medical Guide Sheath Roadster Recalled for Incorrect Dilator Sizing
Merit Medical is recalling Prelude Guide Sheath Roadster devices because some sheaths labeled as .018 dilators may actually contain .038 dilators, creating a risk of using incorrectly-sized medical devices.
Product
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2067-2024·2024-05-29
Medline 20mL Non-Sterile Syringes Recalled for Design Specification Deviation
Medline non-sterile 20mL syringes (Model 91835) are being recalled because the piston sizes and configurations do not match FDA-cleared specifications. Approximately 39,200 units are affected.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2099-2024·2024-05-29
Medical syringes recalled due to manufacturing specification deviation
Medline is recalling 10mL non-sterile syringes manufactured by Jiangsu Shenli Medical because they were produced outside the range of sizes and configurations approved by the FDA. The affected syringes were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1866-2024·2024-05-29
Blood Pump Rotor Model F40015481 Rev A Recalled for Loose Guide Sheaves
Fresenius Medical Care is recalling 45,880 Blood Pump Rotors (Model F40015481 Rev A) due to reports of loose or dislodged guide sheaves after use in clinical facilities.
Product
Blood Pump Rotor, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2024·2024-05-29
Philips Incisive CT Scanner Metal Mounting Box May Expel Fragments
A metal mounting box on the rotating scanner in the Philips Incisive CT system may become damaged and contact other components, potentially expelling fragments at low velocity. This recall affects 155 units distributed nationwide.
Product
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2024·2024-05-29
MEDLINE syringes recalled for sizes outside FDA clearance
MEDLINE is recalling 700 non-sterile 10ML syringes because their piston sizes and configurations exceed the range approved by FDA. No illnesses have been reported. Consumers should stop using these syringes.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2125-2024·2024-05-29
MEDLINE non-sterile syringes recalled for out-of-specification piston configuration
Medline is recalling non-sterile syringes with piston sizes and configurations that exceed the FDA-cleared specification range. The affected devices may not function as originally tested and approved.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2081-2024·2024-05-29
Medline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing
Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2070-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations
Medline is recalling 124,800 non-sterile syringes (model 91838) distributed nationwide because their configurations fall outside specifications cleared by the FDA under the firm's 510(k) approval.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2052-2024·2024-05-29
Non-sterile Medline piston syringes recalled for exceeding FDA scope
Medline has recalled SYR 20ML L/L non-sterile piston syringes (Model 83088) manufactured in sizes and configurations outside FDA-cleared specifications. Approximately 13.6 million units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2054-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Configuration Outside FDA Clearance
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0506-2024·2024-05-29
Haloperidol Decanoate Injections Recalled for Trace Water Contamination
Somerset Therapeutics is recalling Haloperidol Decanoate injections nationwide due to the potential presence of trace amounts of water in some vials, which may affect product quality.
Product
HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2077-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance
MEDLINE has recalled 42,000 non-sterile syringes (Model 91847) because their sizes and configurations exceed FDA-approved specifications. The products were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2024·2024-05-29
FDA recalls GMAX non-sterile syringes sold outside approved specifications
FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.
Product
Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M 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-1881-2024·2024-05-29
SURGIFOAM Absorbable Gelatin Powder Kit Recalled for Open Applicator Tip Seals
Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.
Product
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2024·2024-05-29
2008T BlueStar Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component
Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.
Product
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2024·2024-05-29
FDA Recalls GMAX 5ML Syringes for Out-of-Specification Piston Configuration
Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2043-2024·2024-05-29
Non-sterile Medline syringes recalled for exceeding FDA clearance specifications
Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. are affected.
Product
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2046-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope
Medline is recalling 2.1 million non-sterile syringes (Model 83081) because the piston syringe sizes and configurations exceed the FDA 510(k) clearance scope. Affected products were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide