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

6326–6350 of 13512

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-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-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-1670-2024·2024-05-22
Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination Risk
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in the inner lining. The defect prevents guidewire advancement through the catheter, compromising its function during cardiac procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; 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-1643-2024·2024-05-22
Cardiac catheters recalled due to polyurethane layer delamination defects
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer defects that prevent proper guidewire insertion. Affected devices may experience material detachment in the catheter lining.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; 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-1641-2024·2024-05-22
Boston Scientific Cardiac Catheters Recalled Due to Guidewire Advancement Failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that may prevent guidewire advancement. The recall affects 15,079 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; 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-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-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-1682-2024·2024-05-22
Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Malfunction
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in eight batches affecting 4942 units. The defect prevents guidewire advancement and could compromise device function during cardiac procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; 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-1666-2024·2024-05-22
Boston Scientific Expo 5F catheters recalled for material delamination
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The recall affects 46,860 units distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1680-2024·2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for 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.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1660-2024·2024-05-22
Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect prevents guidewire advancement through 1065 affected devices distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; 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-1674-2024·2024-05-22
Expo 5F Selective Angiographic Catheters recalled for material delamination and device malfunction
Boston Scientific is recalling 1,322 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement. The defect could compromise cardiac catheterization procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1656-2024·2024-05-22
Selective Angiographic Catheters Recalled Due to Material Delamination
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter lining, which may prevent guidewire advancement during medical procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1652-2024·2024-05-22
Cardiac Catheters Recalled Due to Delamination and Device Malfunction
Boston Scientific is recalling 8,725 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; 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-1678-2024·2024-05-22
Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Failure
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment, which may prevent proper guidewire advancement during cardiac procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1649-2024·2024-05-22
Cardiac Catheters Recalled Due to Material Delamination and Guidewire Failure
Boston Scientific is recalling Expo 5F cardiac catheters due to material delamination in the inner lining that prevents guidewire advancement. The defect affects 25,617 units distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; 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-1663-2024·2024-05-22
Expo 5F cardiac catheters recalled for material delamination
Boston Scientific Corporation recalls Expo 5F cardiac catheters due to polyurethane layer delamination and inner lining detachment that prevents guidewire advancement. Affected batch 60535890 has been distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

6326–6350 of 13512