FoodJul 24, 2024
Starter Bakery Multigrain Sourdough Bread with UPC 8 50025 recall — FDA F-1488-2024
Allergen (sesame seeds) declared in the ingredient statement but missing from the "Contains" statement
Class IIFDA: TerminatedSTARTER BAKERY
July 2024 recalls — page 6
These records include useful source details for the selected month.
DrugJul 24, 2024
Pravastatin Sodium Tablets, USP 80mg recall — FDA D-0612-2024
Failed Dissolution Specifications: results below specifications
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugJul 24, 2024
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and recall — FDA D-0608-2024
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
DrugJul 24, 2024
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle recall — FDA D-0607-2024
CGMP Deviations
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugJul 24, 2024
Teva Pharmaceuticals USA Fludrocortisone Acetate Tablets, USP 0.1mg recall — FDA D-0601-2024
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class IIFDA: OngoingTeva Pharmaceuticals USA, Inc.
DrugJul 24, 2024
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle recall — FDA D-0604-2024
Failed Dissolution Specifications
Class IFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugJul 24, 2024
NITROFURANTION Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg recall — FDA D-0597-2024
Failed Dissolution Specifications
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJul 24, 2024
Brands International Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz recall — FDA D-0598-2024
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class IIFDA: OngoingBrands International Corporation
DrugJul 24, 2024
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle recall — FDA D-0605-2024
Failed Dissolution Specifications
Class IFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugJul 24, 2024
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml) recall — FDA D-0610-2024
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class IIFDA: TerminatedHomeocare Laboratories, Inc.
DrugJul 24, 2024
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle recall — FDA D-0606-2024
CGMP Deviations
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
VehicleJul 24, 2024
Tesla latch recall — NHTSA campaign 24V554000
Tesla, Inc. (Tesla) is recalling certain 2021-2024 Model 3, Model S, Model X, and 2020-2024 Model Y vehicles. The hood latch assembly may fail to detect an unlatched hood condition after…
latchTesla, Inc.
VehicleJul 23, 2024
Gulf States Toyota labels recall — NHTSA campaign 24V548000
Gulf States Toyota, Inc. (GST) is recalling certain Toyota 2023 GR Supra, 2024 4 Runner, Corolla, Grand Highlander, Grand Highlander Hybrid, Land Cruiser Hybrid, Tacoma, Tacoma Hybrid,…
labelsGulf States Toyota, Inc.
Medical DeviceJul 17, 2024
GE Vingmed Ultrasound As GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB recall — FDA Z-2316-2024
GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed…
Class IIFDA: OngoingGE Vingmed Ultrasound As
Medical DeviceJul 17, 2024
Maquet Cardiovascular The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed recall — FDA Z-2338-2024
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and…
Class IIFDA: OngoingMaquet Cardiovascular, LLC
Medical DeviceJul 17, 2024
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator recall — FDA Z-2324-2024
G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that…
Class IIFDA: OngoingZoll Medical Corporation
Medical DeviceJul 17, 2024
Fresenius Medical Care Holdings RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor recall — FDA Z-2345-2024
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
Medical DeviceJul 17, 2024
Cardinal Health 200 Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog recall — FDA Z-2327-2024
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied…
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceJul 17, 2024
Fresenius Medical Care Holdings 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump recall — FDA Z-2342-2024
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
Medical DeviceJul 17, 2024
Cardinal Health 200 Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit recall — FDA Z-2328-2024
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied…
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceJul 17, 2024
Pivotal Health Solutions Decompression Table Model E9011 recall — FDA Z-2326-2024
This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the…
Class IIFDA: OngoingPivotal Health Solutions, Inc.
Medical DeviceJul 17, 2024
Fresenius Medical Care Holdings RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood recall — FDA Z-2346-2024
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
Medical DeviceJul 17, 2024
Fresenius Medical Care Holdings 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor recall — FDA Z-2341-2024
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
Medical DeviceJul 17, 2024
Echonous Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a recall — FDA Z-2325-2024
Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other…
Class IIFDA: OngoingEchonous Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.