Safety Recalls
RSS ↗17,567 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 6,551–6,600 of 17,567
- Class I
Medical Device Recall · August 20, 2025
ACCOLADE DR SL (Model L301)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L131, ESSENTIO DR EL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class II
Food Recall · August 20, 2025
CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilantro base that takes no time to rehydrate. NET WT 4.0 OZ (115G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDEUndeclared Yellow #5 and Yellow #6.
- Class I
Medical Device Recall · August 20, 2025
ACCOLADE DR EL (Model L321)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class II
Drug Recall · August 20, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Class II
Medical Device Recall · August 20, 2025
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
- Unclassified
Vehicle Recall · August 20, 2025
2025 ASTON MARTIN VANQUISHA loss of power brake assist can extend the distance required to stop the vehicle, increasing the risk of a crash.
- Class I
Medical Device Recall · August 20, 2025
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, PackSpecific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
- Class I
Medical Device Recall · August 20, 2025
Model Number U125, VALITUDE CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Unclassified
Vehicle Recall · August 20, 2025
2025 MERCEDES-BENZ GLC 300, 2025 MERCEDES-BENZ EQE 350 4MATIC, 2025 MERCEDES-BENZ GLC 300 4MATIC, 2025 MERCEDES-BENZ AMG GLC43 4MATIC COUPEA loose steering coupling can cause a loss of steering control, increasing the risk of a crash.
- Class II
Food Recall · August 20, 2025
Lemon Meringue Pie, 8" round. Net Wt. 27 OZ; Refrigerate after opening Item Code 31811; UPC: 8 85523 31811 1;Jessie's Lemon Meringue Pie Sugar Free Item Code 30811; UPC: 8 85523 30811 2; Jessie's LemUndeclared Yellow#5 in Lemon Meringue Pie
- Class I
Medical Device Recall · August 20, 2025
Model Number L211 PROPONENT DR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
ACCOLADE DR EL MRI (Model L331)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L121 ESSENTIO DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L110, ESSENTIO SR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number U228, VISIONIST CRT-P EL MRISoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number S701 ALTRUA 2 SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
ACCOLADE SR SL (Model L300)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L100, ESSENTIO SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number S722, ALTRUA 2 DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class II
Food Recall · August 20, 2025
Toto S'Mores Ooey Gooey Cookie; Gluten Free & Dairy Free; Net Wt. 2.25 OZ Rear panel: Packed with superfoods; Gluten, Dairy & Soy Free UPC: 860010409398Product label contains conflicting statements about inclusion and being free of Soy ingredient.
- Class II
Drug Recall · August 20, 2025
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-3Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class I
Medical Device Recall · August 20, 2025
Model Number S702, ALTRUA 2 DR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
ACCOLADE DR SL MRI (Model L311)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L231, PROPONENT DR EL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L209 PROPONENT DR (VDD) SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number U225 VISIONIST CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L210 PROPONENT SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number U128, VALITUDE CRT-P EL MRISoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class I
Medical Device Recall · August 20, 2025
Model Number L101, ESSENTIO DR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Class II
Food Recall · August 20, 2025
CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped with egg and cheese. NET WT 3.5 OZ (100G) INGREDIENTS: *** VEGETUndeclared Yellow #5 and Yellow #6.
- Class II
Food Recall · August 19, 2025
Hershey s Ice Cream, Green Mint Chip (GMC) Bulk, 3 gallons, 1 unit , bulk can- a cardboard tub with metal rings and cardboard lidProduct tested elevated coliform counts during routine testing
- Class II
Medical Device Recall · August 19, 2025
Greiner Bio-One North America, Inc.
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel SepaSome of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
- Class II
Drug Recall · August 19, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., PhiladelphPresence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
- Unclassified
Vehicle Recall · August 19, 2025
Triumph Motorcycles America, Ltd.
2025 TRIUMPH DAYTONA 660Engine failure increases the risk of a crash.
- Class II
Food Recall · August 19, 2025
Southwind Foods LLC dba Great American Seafood Imports Co.
Sand Bar; Great American; and First Street branded Frozen raw shrimp; 2 pound plastic bag; UPC#: 011110641182; 829944010612; 041512179471; 829944010698; 8299440106636Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Class II
Food Recall · August 19, 2025
Southwind Foods LLC dba Great American Seafood Imports Co.
Best Yet; Arctic Shores; and Great American branded Frozen cooked shrimp; 1 Pound/ 12 OZ/ 6 OZ/ 2 Pound plastic bag; (Various Brands) UPC#: 042187002736; 042187002743; 041130812392; 041130810497; 0411Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Class II
Medical Device Recall · August 18, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿mReviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Class II
Medical Device Recall · August 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- Class II
Medical Device Recall · August 18, 2025
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Class II
Medical Device Recall · August 18, 2025
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Class II
Drug Recall · August 18, 2025
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: AmnealPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Unclassified
Vehicle Recall · August 18, 2025
2026 RAM 3500An incorrect warning light can fail to alert the driver to critical safety information, increasing the risk of a crash.
- Class II
Drug Recall · August 18, 2025
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: AmnealPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class II
Drug Recall · August 18, 2025
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: AmnealPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class II
Medical Device Recall · August 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- Class II
Medical Device Recall · August 18, 2025
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Class I
Drug Recall · August 18, 2025
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09Presence of Particulate Matter.