State

American Samoa product recalls

73,096 recalls have nationwide distribution and so reach American Samoa. 25 additional recalls listed American Samoa specifically in their distribution scope.

What the numbers show

Total: 25
Critical: 1
Severe: 5
Most recent: 2026-09-09

Of the 25 recalls naming American Samoa we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (20%) are Severe.

Which agencies issued them

These figures cover only the 25 recalls whose distribution notice names American Samoa specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

11176–11200 of 73121

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-2060-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Specification Manufacturing
Medline brand non-sterile 5mL syringes (Model 91828) are being recalled because the piston syringe sizes and configurations exceed the manufacturer's FDA 510(k) clearance specifications. The recall affects 22,400 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 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-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 (Devices)·Z-2055-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations
Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 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-1848-2024·2024-05-29
Philips Recalls Ingenia 3.0T MR Systems for Loose Mains Terminal Fire Hazard
Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot and cause fire or smoke.
Product
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2024·2024-05-29
Philips Sonalleve MR HIFU 3.0T diagnostic system fire risk recall
Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.
Product
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
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-1849-2024·2024-05-29
MRI Scanner Terminal Connection Fire and Smoke Risk
Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.
Product
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1860-2024·2024-05-29
MRI System Mains Distribution Unit Connection Fire Risk
Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.
Product
SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
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-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
HighFDA (Devices)·Z-2105-2024·2024-05-29
Wolf Medical Syringes Recalled for Exceeding Approved Specifications
Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.
Product
Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L 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-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-2126-2024·2024-05-29
Medline non-sterile syringes recalled for out-of-specification manufacturing
Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1839-2024·2024-05-29
Philips Achieva 3.0T MRI System Recall: Fire Hazard Risk
Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.
Product
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
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-2127-2024·2024-05-29
Non-Sterile Syringes Recalled for Regulatory Non-Compliance and Design Deviation
Jiangsu Shenli Medical is recalling 7,000 MEDLINE non-sterile syringes because their sizes and configurations exceed FDA 510(k) approval. The syringes were distributed nationwide and may pose infection risks.
Product
Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2024·2024-05-29
Magnetic Resonance System Loose Terminal Connection May Cause Fire
Philips MR RT imaging systems may have loose electrical connections that could cause smoke or fire in hospital technical rooms. Two units with serial numbers 45 and 47 are affected worldwide.
Product
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
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
HighFDA (Devices)·Z-2050-2024·2024-05-29
Non-Sterile Syringes Recalled Due to Manufacturing Specification Violation
Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2024·2024-05-29
Medline 10mL Syringes Recalled Due to Non-Conforming Device Configuration
Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for single use Component: No
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