Safety Recalls

15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 12,351–12,400 of 15,379

• Food Recall · May 2, 2024

  Newly Weds Foods, Inc.

  Newly Weds Foods, LLC G51904 Steak and Burger Seasoning 5lb. case

  Potential Salmonella contamination - ingredient

  Class I

• Food Recall · May 2, 2024

  Maribel's Sweets, Inc.

  7. 7pc Mother s Day heart box

  Contains undeclared coconut.

  Class II

• Food Recall · May 2, 2024

  Newly Weds Foods, Inc.

  Newly Weds Foods, LLC E50792 Breader X1 50lb bag

  Potential Salmonella contamination - ingredient

  Class I

• Food Recall · May 2, 2024

  Hormel Foods Corporation

  PLANTERS¿ Deluxe Lightly Salted Mixed Nuts 8.75 oz. UPC 2900001621. Packaged in a metal corrugate can with plastic lid. 12 cans per case.

  Possible contamination with Listeria monocytogenes

  Class I

• Food Recall · May 2, 2024

  Maribel's Sweets, Inc.

  1. 2pc Ganache tote box

  Contains undeclared coconut.

  Class II

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Bravo 500 Functional Whey Protein SKU 32103. 34% Protein. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 25

  Possible Salmonella contamination.

  Class I

• Drug Recall · May 1, 2024

  Dr. Reddy's Laboratories, Inc.

  Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

  Failed Impurities/Degradation Specifications

  Class III

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Grande Primo Y45 Cultured Dairy Product. Product Code: 32400. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate, Skim Milk, Yogurt Cultures (L. bulgaricus, S. the

  Possible Salmonella contamination.

  Class I

• Medical Device Recall · May 1, 2024

  Getinge Usa Sales Inc

  Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.

  Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.

  Class I

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Bravo 250 Functional Whey Protein SKU 32101. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive

  Possible Salmonella contamination.

  Class I

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Bravo 300 Functional Whey Protein SKU 32102. 34% Protein. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 25

  Possible Salmonella contamination.

  Class I

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Lactose SKU 30600. Grade A. Refined Pasteurized. Net Wt 25 kg. Ingredients: Lactose Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive, Fond du Lac, WI

  Possible Salmonella contamination.

  Class I

• Drug Recall · May 1, 2024

  Pharma Nobis LLC

  Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9

  Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

  Class II

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Bravo 600 Functional Whey Protein SKU 32106. 34% Protein. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 25

  Possible Salmonella contamination.

  Class I

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Ultra 9100 Functional Whey Protein Isolate. SKU 32131. 90% Protein. Grade A. Pasteurized. Net Wt 20 kg. Ingredients: Whey Protein Isolate Contains Milk. Grande Custom Ingredients Grou

  Possible Salmonella contamination.

  Class I

• Drug Recall · May 1, 2024

  Pharma Nobis LLC

  CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.

  Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

  Class II

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Lactose. SKU 30601. Grade A. Refined Pasteurized. Net Wt 25 kg. Ingredients: Lactose Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive, Fond du Lac, WI

  Possible Salmonella contamination.

  Class I

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Ultra 8000 Nutritional Whey Protein Isolate. SKU 32200. 80% Protein Dry Basis. Grade A. Pasteurized. Net Wt 20 kg. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom

  Possible Salmonella contamination.

  Class I

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Bravo 550 Functional Whey Protein SKU 32105. 34% Protein. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 25

  Possible Salmonella contamination.

  Class I

• Food Recall · May 1, 2024

  GRANDE CHEESE COMPANY

  Grande Ultra 9150 Whey Protein Isolate. Product Code: 32324. 90% Protein. Grade A. Pasteurized. Net Wt 20 kg. Ingredients: Whey Protein Isolate Contains Milk. Manufactured By: Grande Custo

  Possible Salmonella contamination.

  Class I

• Medical Device Recall · May 1, 2024

  Mermaid Medical A/S

  The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spi

  Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

  Class II

• Medical Device Recall · April 30, 2024

  ZOLL Medical Corporation

  ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2

  Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy

  Class I

• Drug Recall · April 30, 2024

  Hikma Injectables USA Inc

  Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by

  Labeling: Wrong Barcode

  Class III

• Medical Device Recall · April 30, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)

  There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors

  Class II

• Food Recall · April 30, 2024

  BAKERLY BARN LLC

  Marketside Brioche Rolls, Authentic French Recipe, Net Wt. (.88 OZ (280g)

  Product contains undeclared soy lecithin.

  Class II

• Medical Device Recall · April 30, 2024

  St. Jude Medical

  St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

  One lot of product has dilators that are too short and will not extend outside the introducer sheath.

  Class II

• Medical Device Recall · April 30, 2024

  Outset Medical, Inc.

  TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodial

  A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.

  Class II

• Drug Recall · April 30, 2024

  Viatris Inc

  Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10

  Failed Impurities/Degradation Specifications

  Class II

• Drug Recall · April 30, 2024

  Viatris Inc

  Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

  Failed Impurities/Degradation Specifications

  Class II

• Food Recall · April 29, 2024

  El Mirasol, Inc.

  Tortilla de Harina, 400 gr, 10 count, packaged in clear plastic bag, 20 packages per case.

  Undeclared allergen: Wheat

  Class II

• Medical Device Recall · April 29, 2024

  Pivotal Health Solutions, Inc.

  Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.

  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 faulty E7130-B part that were manufactured, but had not been distributed yet.

  Class II

• Medical Device Recall · April 29, 2024

  ARROW INTERNATIONAL Inc.

  Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

  Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

  Class I

• Drug Recall · April 29, 2024

  Hikma Injectables USA Inc

  Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

  Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

  Class I

• Drug Recall · April 29, 2024

  Breckenridge Pharmaceutical, Inc

  Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Ber

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

  Class II

• Medical Device Recall · April 29, 2024

  Verathon, Inc.

  Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor

  Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

  Class II

• Drug Recall · April 29, 2024

  Breckenridge Pharmaceutical, Inc

  Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Bar

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

  Class II

• Medical Device Recall · April 29, 2024

  ARROW INTERNATIONAL Inc.

  Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

  Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

  Class I

• Drug Recall · April 29, 2024

  Breckenridge Pharmaceutical, Inc

  Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc.,

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

  Class II

• Medical Device Recall · April 29, 2024

  Nihon Kohden America Inc

  BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital sig

  Due to software issue the device may give false "SpO2 Probe Failure" alarm

  Class II

• Medical Device Recall · April 29, 2024

  Verathon, Inc.

  Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor

  Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

  Class II

• Medical Device Recall · April 29, 2024

  ARROW INTERNATIONAL Inc.

  Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

  Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

  Class I

• Food Recall · April 27, 2024

  H-E-B San Antonio Retail Support Center (SARSC)

  3-ounce H-E-B Creamy Creations Chocolate Ice Cream-12 pk

  Potential metal contamination

  Class II

• Food Recall · April 27, 2024

  H-E-B San Antonio Retail Support Center (SARSC)

  3-ounce H-E-B Creamy Creations Ice Cream Homemade/Chocolate Combo -12 pack

  Potential metal contamination

  Class II

• Food Recall · April 27, 2024

  H-E-B San Antonio Retail Support Center (SARSC)

  3-ounce H-E-B Creamy Creations Ice Cream Lime/Orange Combo - 12 pack

  Potential metal contamination

  Class II

• Food Recall · April 27, 2024

  CN Frozen Foods, INC

  Sysco Classic Riced Cauliflower packed in a 4lb plastic bag (6 units of 4 lb. per carton box).

  Riced Cauliflower tested positive for Listeria monocytogenes.

  Class II

• Medical Device Recall · April 26, 2024

  Medtronic Navigation, Inc.-Littleton

  O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000

  Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.

  Class II

• Medical Device Recall · April 26, 2024

  Exactech, Inc.

  Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R;

  The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

  Class II

• Medical Device Recall · April 26, 2024

  Centers For Disease Control and Prevention

  CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

  The H5b component may fail to amplify, resulting in an inconclusive result.

  Class II

• Drug Recall · April 26, 2024

  Rubicon Research Private Limited

  traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Resea

  Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

  Class II

• Food Recall · April 26, 2024

  DANONE US LLC

  YoCrunch¿ Vanilla Lowfat Yogurt with M&Ms 18 6oz cups per case

  Undeclared wheat

  Class II