Safety Recalls

15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 7,901–7,950 of 15,271

• Food Recall · February 15, 2025

  ZB Importing LLC

  Ulker Dankek Roll Cake Strawberry , item 8298, 8.3oz foil pack, 8 per case, UPC 8690504066828

  Milk not listed in Contains statement

  Class II

• Medical Device Recall · February 15, 2025

  Abbott Medical

  Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantati

  Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

  Class II

• Food Recall · February 15, 2025

  ZB Importing LLC

  Ulker Biskrem Cocoa Biscuit, item 8836, 10.6oz foil pack, 8 per case, UPC 8690504114628

  Undeclared wheat and egg

  Class I

• Food Recall · February 15, 2025

  ZB Importing LLC

  Ulker Dankek Roll Cake Chocolate, item 9584, 3oz foil pack, 8 per case, UPC 8690504067979

  Egg not listed in Contains statement

  Class II

• Food Recall · February 15, 2025

  Great Lakes Cheese Co Inc

  Happy Farms by ALDI Colby Jack (a blend of Colby & Monterey Jack finely shredded cheeses), Net Wt. 12 OZ (340g), packaged in flexible plastic stand-up pouches, 12 pouches per case, UPC 4061463330840,

  Potential foreign material (stainless steel fragments)

  Class II

• Food Recall · February 15, 2025

  ZB Importing LLC

  Ulker Kekstra Mini strawberry, item 3792, 5.3oz foil pack, 10 per case, UPC 8690766082307

  Milk not declared as the major food allergen source for the ingredient Whey

  Class II

• Food Recall · February 15, 2025

  ZB Importing LLC

  Ulker Dankek Roll Cake Banana, item 9620, 8.3oz foil pack, 8 per case, UPC 8690504067986

  Wheat not listed in Contains statement

  Class II

• Food Recall · February 15, 2025

  NATURIPE VALUE ADDED FRESH LLC

  Berry Buddies; Blueberries, Mini Pancakes & Real Maple Syrup; NET WT 2.1 oz (60 g); 3-compartment non-flex plastic container with heat-sealed plastic film containing mini pancakes, blueberries, and ma

  Incorrect back label on product resulting in undeclared allergens (wheat, eggs)

  Class I

• Food Recall · February 15, 2025

  ZB Importing LLC

  Ulker Rulokat Hazelnut Wafers, item 3865, 6oz plastic cylinder, 6 per case, UPC 8690766086473

  Undeclared egg

  Class I

• Food Recall · February 14, 2025

  The Karma Sauce Company LLC

  HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5

  Possible foreign object contamination (plastic).

  Class II

• Medical Device Recall · February 14, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

  A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

  Class II

• Drug Recall · February 14, 2025

  CareFusion 213, LLC

  BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Appl

  Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

  Class I

• Medical Device Recall · February 14, 2025

  Smiths Medical ASD, Inc.

  CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

  Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

  Class II

• Medical Device Recall · February 14, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

  A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

  Class II

• Food Recall · February 14, 2025

  Mauna Loa Macadamia Nut Company, LLC

  Mauna Loa Milk Chocolate Covered Macadamias product is a snack product and packaged in plastic 1oz pouch. Each carton contains 12 pouches, and each master case contains 12 cartons. Retail Pouch (1oz

  Undeclared almonds

  Class I

• Food Recall · February 14, 2025

  The Karma Sauce Company LLC

  HOT ONES brand ROJO, Los Calientes Hot Sauce, BY HEATONIST; 5 oz size and 1 gallon sizes; UPC: 8-51444-00810-03

  Possible foreign object contamination (plastic).

  Class II

• Medical Device Recall · February 14, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

  A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

  Class II

• Medical Device Recall · February 14, 2025

  Smiths Medical ASD, Inc.

  CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

  Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as FACE LIFT. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAP

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Consumer Product Recall · February 13, 2025

  SHEIN Distribution Corporation, of Los Angeles, California

  SHEIN EVRYDAY Kids' Pajama Sets

  The recalled children's pajamas violate the federal flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

  Unclassified

• Drug Recall · February 13, 2025

  World Perfumes Inc.

  Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 7

  Defective Container: broken or leaking bottles.

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product D

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (A

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Consumer Product Recall · February 13, 2025

  BlockBlueLight Limited, of New Zealand

  Multi-Mode Sleep Lamps

  The lithium-ion battery in the recalled portable lamps can overheat while charging, posing fire and burn hazards to consumers.

  Unclassified

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Drug Recall · February 13, 2025

  Johnson, S C and Son, Inc

  Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813

  Chemical Contamination

  Class II

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated ext

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Remel, Inc

  remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

  Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Consumer Product Recall · February 13, 2025

  DMITOY, of China

  6-in-1 Pounding Games

  The recalled 6-in-1 Pounding Game violates the mandatory federal regulation for magnets because it contains a magnet that can become loose, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.

  Unclassified

• Drug Recall · February 13, 2025

  ICU Medical, Inc.

  POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

  Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

  Class I

• Drug Recall · February 13, 2025

  Zydus Pharmaceuticals (USA) Inc

  Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd,

  Failed Impurities/Degradation Specifications

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Drug Recall · February 13, 2025

  ICU Medical, Inc.

  POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (

  Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for t

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  Remel, Inc

  remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

  Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

  Class II

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for t

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-8

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Consumer Product Recall · February 13, 2025

  Target Corporation, of Minneapolis, Minnesota

  Spritz Taper Resin Hanukkah Dino Menorahs

  The recalled resin menorahs can burn or catch fire when holding lit candles, posing a fire hazard.

  Unclassified