Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

6301–6325 of 13512

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
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-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-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-2056-2024·2024-05-29
MEDLINE Non-Sterile Syringes Model 91822 Recalled for Unapproved Configuration
MEDLINE non-sterile syringes (Model 91822) are recalled because their sizes and configurations fall outside the FDA-approved range under the manufacturer's 510(k) clearance. Approximately 12,000 units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2051-2024·2024-05-29
Non-sterile syringes recalled for manufacturing outside FDA-cleared specifications
Jiangsu Shenli Medical is recalling 619,200 MEDLINE non-sterile syringes (Model 83087) manufactured in configurations outside FDA-approved specifications. The recall affects units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2076-2024·2024-05-29
Medline 10ML Syringes Recalled Due to Regulatory Specification Non-Compliance
Medline is recalling 10ML syringes in multiple lot codes because the device sizes fall outside the range cleared by the FDA for this product. The affected products were distributed to consumers in six states.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1665-2024·2024-05-22
Expo Selective Angiographic Catheters Recalled for Material Delamination and Detachment
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during cardiac procedures. Affected batches 60443927 and 60495422 have been distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1685-2024·2024-05-22
Boston Scientific cardiac catheters recalled for delaminating polyurethane and guidewire advancement failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to complaints of guidewire advancement problems and polyurethane delamination in the catheter lining. Affected catheters are distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1681-2024·2024-05-22
Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Issues
Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1671-2024·2024-05-22
Expo 5F Cardiac Catheters recalled due to polyurethane delamination
Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1657-2024·2024-05-22
Boston Scientific Cardiac Catheters Recalled for Material Delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination of the inner lining. The defect prevents guidewire advancement and affects 330 units worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1648-2024·2024-05-22
Expo 5F Selective Angiographic Catheters recalled for delamination risk
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in select batches due to polyurethane layer delamination and material detachment that could prevent guidewire advancement during use.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1644-2024·2024-05-22
Selective Angiographic Catheters recalled for material delamination and detachment
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect may prevent proper guidewire advancement during cardiac procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1647-2024·2024-05-22
Angiographic Catheters Recalled for Polyurethane Delamination and Malfunction
Boston Scientific recalls Expo 5F angiographic catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The recall affects 3,127 units in specific batches distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1672-2024·2024-05-22
Expo Cardiac Catheters Recalled Due to Delamination and Guidewire Advancement Failure
Boston Scientific has recalled Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The defect affects certain batch numbers in catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1650-2024·2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment in the catheter's inner lining, which prevents proper advancement of the guidewire.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1655-2024·2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific recalled Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in certain batches, which can prevent guidewire advancement during cardiac procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1661-2024·2024-05-22
Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment
Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1642-2024·2024-05-22
Boston Scientific Cardiac Catheters Recalled for Material Delamination
Boston Scientific is recalling certain Expo 5F cardiac catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during procedures. The recall affects 290 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1646-2024·2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Inner Lining Material Failure
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter's inner lining. This prevents guidewire advancement through the catheter.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1673-2024·2024-05-22
Boston Scientific Cardiac Catheters Recalled for Inner Lining Delamination
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the inner lining, which can prevent guidewire advancement.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1662-2024·2024-05-22
Cardiac Catheters Recalled for Material Delamination Risk
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters worldwide due to polyurethane delamination and material detachment that prevents guidewire advancement.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1658-2024·2024-05-22
Cardiac catheters recalled for guidewire advancement failure due to material delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures. The recall affects 4,715 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1684-2024·2024-05-22
Expo 5F Cardiac Catheters recalled due to delamination defect
Boston Scientific is recalling 8,715 Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane delamination that prevents guidewire advancement. The affected units were distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
Category
Medical Device
Distribution
0 states

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6301–6325 of 13512