Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8801–8825 of 53036

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-2124-2024·2024-05-29
GMAX SYR 5ML syringes recalled for unapproved piston configurations
FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.
Product
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M 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 (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 (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-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-1843-2024·2024-05-29
Evolution 1.5T MR Systems: Loose Terminal Connection Fire Risk
Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed worldwide.
Product
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
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-2114-2024·2024-05-29
GMAX SYR 30ML/LL Syringes Recalled for Exceeding 510(k) Clearance
GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2100-2024·2024-05-29
Disposable Luer Lock Syringes Recalled for Exceeding Cleared Specifications
Jiangsu Shenli Medical recalled approximately 110,000 MEDIGRATIVE disposable syringes because the manufactured units exceed specifications approved by the FDA.
Product
Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2024·2024-05-29
Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance
Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.
Product
Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
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-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 (Food)·F-1257-2024·2024-05-29
Mucci's Tiramisu Italian Dessert Recalled Due to Undeclared Milk
Mucci Food Products, Ltd. is recalling Tiramisu Italian Dessert due to undeclared milk and incomplete allergen labeling. Consumers with milk allergies are at risk.
Product
Mucci Food Products, Ltd. Tiramisu Italian Dessert, 2, 4.25 lb trays per case
Category
Food
Distribution
1 state
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-1870-2024·2024-05-29
Hemodialysis Machine Blood Pump Rotor Guide Sheave Failure Recall
Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.
Product
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1887-2024·2024-05-29
Siemens IMMULITE 2000 Anti-TG Ab Test Kits Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.
Product
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
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-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-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-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 (Food)·F-1261-2024·2024-05-29
Wegmans Half Loaf Garlic Bread Recalled Due to Undeclared Milk
Wegmans Food Markets is recalling Wegmans Half Loaf Garlic Bread due to undeclared milk. The product may pose a risk to consumers with milk allergies.
Product
Wegman's Half Loaf Garlic Bread
Category
Food
Distribution
2 states
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-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