Safety Recalls
RSS ↗15,200 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 4,251–4,300 of 15,200
- Class II
Food Recall · September 25, 2025
tru fru Dark + White Chocolate Freeze-Dried Strawberries. 1.7oz retail pouch UPC 850048358331. 12 retail units per case. 3.4oz retail pouch UPC 850048358270. 6 retail units per case. 13oz retail poupotential for metal in product
- Class II
Medical Device Recall · September 25, 2025
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
- Class I
Food Recall · September 25, 2025
COOKED FETTUCCINE PASTA 6 X 5 lbs pouches Net Weight: 30 lbs (13.60 kg) PERISHABLE KEEP FROZENPotential contamination with Listeria monocytogenes.
- Class II
Food Recall · September 25, 2025
tru fru Strawberries + Creme Freeze-Dried Fresh, retail pouch 3.4oz UPC 850048358249, 6 retail units per casepotential for metal in product
- Class I
Food Recall · September 25, 2025
MAP COOKED FETTUCCINE PASTA 6 x 5 lbs pouches Net Weight: 30 lbs (13.60kg) PERISHABLE KEEP REFRIGERATEDPotential contamination with Listeria monocytogenes.
- Class II
Medical Device Recall · September 25, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
- Class II
Medical Device Recall · September 25, 2025
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
- Class I
Medical Device Recall · September 25, 2025
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: TheDue to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
- Class II
Medical Device Recall · September 25, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
- Class II
Medical Device Recall · September 25, 2025
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
- Unclassified
Consumer Product Recall · September 25, 2025
Hoovy Cooling Gel Insert Pads for Car Seats and StrollersThe cooling gel pads can become hot if left in the sun or a hot car, posing a burn hazard to young children.
- Unclassified
Consumer Product Recall · September 25, 2025
Sichuan Yunduan Renjia Trading Co. Ltd., of China, doing business as Walmart seller Autoez
Autoez Bamboo ShadesThe recalled shades have long operating cords and accessible inner cords that can cause death or serious injury to children, due to strangulation and entanglement hazards. The shades violate the federal rule for window coverings and present a substantial product hazard. In addition, the shades also violate labeling requirements for window coverings.
- Class II
Food Recall · September 24, 2025
Orwashers brand Soho Sourdough XL Batard; contains: wheat; 6-46.4oz PIECES PER CASEMislabeled: Product may contain undeclared sesame seeds
- Class II
Drug Recall · September 24, 2025
Zydus Pharmaceuticals (USA) Inc
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-92Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- Class II
Medical Device Recall · September 24, 2025
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/AIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Class II
Medical Device Recall · September 24, 2025
Stryker Sustainability Solutions
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLYDue to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
- Class II
Drug Recall · September 24, 2025
Zydus Pharmaceuticals (USA) Inc
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- Class II
Medical Device Recall · September 24, 2025
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/AIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Class II
Food Recall · September 24, 2025
NOW Real Food Organic Unsalted Whole Raw Cashews, 10 oz. pouch, UPC 7 33739 07066 1 Product Code 7066Undeclared pine nut
- Class II
Medical Device Recall · September 24, 2025
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER ComponIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Class II
Medical Device Recall · September 24, 2025
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/AIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Class II
Medical Device Recall · September 23, 2025
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint RepairThere is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
- Class II
Drug Recall · September 23, 2025
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- Class II
Food Recall · September 23, 2025
Southwind Foods LLC dba Great American Seafood Imports Co.
Arctic Shores; Best Yet; Great American; Master Catch branded Frozen Raw shrimp; 2lbs; 1lbs; UPC: 041130810923; 041512179471; 041130810978; 041130811029; 011110641182; 829944010636; 041130811333; 04Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
- Class II
Medical Device Recall · September 23, 2025
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Food Recall · September 23, 2025
Southwind Foods LLC dba Great American Seafood Imports Co.
Great American branded Frozen raw shrimp skewer; 1lb bag UPC: 829944002716; 829944002372Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
- Class III
Food Recall · September 23, 2025
Scott & Jon s Honey Sesame Salmon Rice Bowlcontains undeclared wheat
- Class III
Food Recall · September 23, 2025
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.
- Class II
Food Recall · September 23, 2025
Wawa Strawberry Milk, Lowfat Milk, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191015134Potential foreign object contamination
- Class III
Food Recall · September 23, 2025
YO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehProduct contains undeclared cyclamates.
- Class II
Drug Recall · September 23, 2025
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015Product Mix-up
- Class II
Medical Device Recall · September 23, 2025
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class III
Food Recall · September 23, 2025
YO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potasProduct contains undeclared cyclamates.
- Class II
Food Recall · September 23, 2025
Southwind Foods LLC dba Great American Seafood Imports Co.
Tovala branded Frozen raw phosphate free shrimp; 5oz IQF bag UPC: 829944085788Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
- Class II
Food Recall · September 23, 2025
Wawa HVD (Whole) Milk , 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191014403Potential foreign object contamination
- Class II
Medical Device Recall · September 23, 2025
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · September 23, 2025
iLet Bionic Pancreas, REF: BB1001The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.
- Class II
Food Recall · September 23, 2025
Southwind Foods LLC dba Great American Seafood Imports Co.
Arctic Shores; Best Yet; Great American; Master Catch branded Frozen cooked shrimp; 2lbs; 1lbs; 12oz bags; UPC: 041130810497; 041130810411; 041130811685; 041130810817; 042187002705; 829944012623; 04Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
- Class II
Food Recall · September 23, 2025
Wawa Strawberry Lemonade, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 007626191018982Potential foreign object contamination
- Class II
Food Recall · September 23, 2025
El Rojo Pasta De Harina, Wheat Pellets. Net Wt 8 oz. (225g) UPC 0 35579-80871 6. Packaged and distributed by: El Rojo Wholesale, Maple Grove, MN 55469.Product is missing the ingredient list (which lead to missing wheat and Yellow No. 6), and a nutritional panel.
- Class II
Food Recall · September 23, 2025
Southwind Foods LLC dba Great American Seafood Imports Co.
Arctic Shores branded Frozen cooked salad shrimp; 6 oz bag UPC: 041130811685Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
- Class II
Medical Device Recall · September 23, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · September 23, 2025
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · September 23, 2025
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolaPotential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- Class II
Medical Device Recall · September 23, 2025
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · September 22, 2025
Siemens Healthcare Diagnostics, Inc.
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
- Class II
Food Recall · September 22, 2025
Dr. Praeger's Sensible Foods Inc.
Dr. Praeger's, California Veggie Burgers, 10oz, Plastic wrapped burgers inside of a retail box. 6 packages per master case. Keep FrozenProduct was made on equipment that test positive for Listeria .
- Class II
Drug Recall · September 22, 2025
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.Lack of assurance of sterility.
- Class II
Food Recall · September 22, 2025
Sea Port brand, Raw Frozen Easy Peel Headless Shell-On White Shrimp, Jumbo size 16-20. Product of Indonesia. Distributed by Sea Port Products Corporation, Kirkland, WA. Master Case: 10/2 lbs. bags. NeShrimp may be contaminated with Cesium-137 (Cs-137).
- Class II
Medical Device Recall · September 22, 2025
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent dDue to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.