Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

951–975 of 4878

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-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-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-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-1677-2024·2024-05-22
Cardiac Catheters Recalled Due to Defective Polyurethane Layer
Boston Scientific recalls 1,015 Expo 5F selective angiographic catheters due to polyurethane layer delamination that prevents guidewire advancement. The defect affects multiple batches distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; 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-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
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-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-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-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-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
SevereCPSC·24235·2024-05-16
Electrolux Frigidaire and Kenmore Electric Ranges Recalled for Fire and Burn Hazards
Electrolux is recalling about 203,000 Frigidaire and Kenmore smooth-top electric ranges because heating elements can turn on unexpectedly, fail to turn off, or heat incorrectly, posing fire and burn risks. At least 212 incidents have been reported since 2009, including 14 fires and 8 burn injuries.
Product
Frigidaire and Kenmore Smooth-top Freestanding Electric Ranges
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Food)·F-1224-2024·2024-05-15
D-LO's Pistachio Cheesecake Recalled for Undeclared Allergens and Food Coloring
D-LO's Delightful Gourmet Cheesecake in pistachio flavor is being recalled due to undeclared wheat and soy allergens and undeclared food colors. The product poses a health risk to consumers with allergies to these ingredients.
Product
D-LO's Delightful Gourmet Cheesecake, Pistachio, 142g single serve UPC 8 60007 40398 9, and 678g six serving UPC 8 60007 40395 8, both serving sizes in clear plastic container with hinged lid
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-0486-2024·2024-05-15
Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency
Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.
Product
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1233-2024·2024-05-15
Belgian Yummies Salted Caramel Ice Cream Cookie Sandwiches recalled for undeclared allergens
Belgian Yummies is recalling Salted Caramel Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, soy, wheat, peanuts, and tree nuts. The recall affects 254 units.
Product
Salted Caramel Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1234-2024·2024-05-15
Key Lime Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens
Belgian Yummies is recalling Key Lime Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, soy, wheat, peanuts, and tree nuts. Consumers with these allergies should not consume the product.
Product
Key Lime Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1733-2024·2024-05-15
Hologic BioZorb Bioabsorbable Markers Recalled for Adverse Events
Hologic is recalling BioZorb Marker bioabsorbable surgical markers due to reported adverse events including infection, pain, device migration, and erosion. FDA classified this as Class I, affecting 53,492 units nationwide.
Product
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Mark
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1230-2024·2024-05-15
Vanilla Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens
Belgian Yummies is recalling Vanilla Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, wheat, peanuts, and tree nuts.
Product
Vanilla Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1609-2024·2024-05-15
Insulin pump app may crash and drain battery, risking insulin delivery interruption
Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.
Product
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1776-2024·2024-05-15
Stealth S8 neurosurgical navigation software display error affecting surgical guidance
Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.
Product
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1236-2024·2024-05-15
Belgian Yummies ice cream recalled for undeclared milk and wheat
Belgian Yummies Homemade Ice Cream Horchata Gelato distributed in Florida is recalled due to undeclared milk and wheat allergens that may affect consumers with allergies.
Product
Belgian Yummies Homemade Ice Cream Horchata Gelato. Packaged in 4.75 Liter gray pan.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1235-2024·2024-05-15
Peanut Butter Ice Cream Cookie Sandwich Recalled: Undeclared Allergens
Belgian Yummies is recalling Peanut Butter Ice Cream Cookie Sandwiches distributed in Florida due to undeclared milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume the product.
Product
Peanut Butter Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1730-2024·2024-05-15
Vyaire Twin Tube Sample Line Nozzle Separation Recall
Vyaire Medical recalls Twin Tube sample line 240 cm devices (Model V-707327) due to potential nozzle separation during patient use. All lots manufactured prior to June 2023 are potentially affected.
Product
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0485-2024·2024-05-15
Prescription Drug Javygtor Recalled for Sub-Potency and Powder Discoloration
Dr. Reddy's Laboratories is recalling Javygtor powder packets nationwide due to powder discoloration and sub-potency. The recall affects 17,332 cartons with multiple lot numbers.
Product
JAVYGTOR — JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide