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

6451–6475 of 13666

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-2118-2024·2024-05-29
FDA Recalls GMAX Syringes Due to Unapproved Configuration
Jiangsu Shenli is recalling GMAX 12ML syringes because the device sizes and configurations exceed what was cleared by FDA. Approximately 303,800 units were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M 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-1669-2024·2024-05-22
Expo 5F Selective Angiographic Cardiac Catheters: Guidewire Advancement Failure Risk
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Cardiac Catheters due to polyurethane delamination that prevents guidewire advancement. The recall affects 15,270 units distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1653-2024·2024-05-22
Expo 5F cardiac angiographic catheters recalled for delamination defect
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the catheter lumen.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1683-2024·2024-05-22
Boston Scientific cardiac catheters recalled for polyurethane delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. Approximately 37,252 catheters in specific batches are affected worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; 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-1667-2024·2024-05-22
Expo 5F Angiographic Catheters Recalled for Guidewire Advancement Failure
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; 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-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-1638-2024·2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling Expo 5F catheters due to polyurethane delamination and material detachment preventing guidewire advancement. The recall affects approximately 16,797 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; 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-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-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
SevereFDA (Devices)·Z-1639-2024·2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Polyurethane Delamination
Expo 5F Selective Angiographic Catheters are recalled because polyurethane layer delamination and material detachment prevent guidewire advancement. Approximately 297,479 affected catheters have been distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1659-2024·2024-05-22
Expo selective angiographic cardiac catheters recalled for guidewire advancement failure
Boston Scientific is recalling Expo 5F selective angiographic catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1664-2024·2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling specific batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The affected catheters may not function properly during angiographic procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; 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-1640-2024·2024-05-22
Expo 5F Selective Angiographic Catheters recalled due to material delamination
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane layer delamination that prevents guidewire advancement. The inner lining material may detach, making the catheters unsafe to use.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1676-2024·2024-05-22
Expo 5F Catheters Recalled for Guidewire Advancement Failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The issue affects 440 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
Category
Medical Device
Distribution
0 states

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6451–6475 of 13666