Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 13,601–13,650 of 15,379
- Class II
Drug Recall · February 19, 2024
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX HCGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class I
Medical Device Recall · February 19, 2024
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief,Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
- Class II
Medical Device Recall · February 19, 2024
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 4236Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
- Class II
Medical Device Recall · February 17, 2024
Olympus Corporation of the Americas
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting oA deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- Class II
Medical Device Recall · February 17, 2024
Olympus Corporation of the Americas
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisA deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- Class I
Food Recall · February 16, 2024
Raw Cheddar Cheese, made from unpasteurized milk, 16 oz (1 lb) block, Keep Refrigerated under 40 degreesPotential contamination with E. coli O157:H7
- Class II
Medical Device Recall · February 16, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060ALow concentration of sodium pyruvate in the wash could compromise gamete development
- Class II
Medical Device Recall · February 16, 2024
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steeraDue to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
- Class II
Medical Device Recall · February 16, 2024
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010ALow concentration of sodium pyruvate in the wash could compromise gamete development
- Class I
Food Recall · February 16, 2024
Raw Cheddar Cheese, made from unpasteurized milk, 8 oz (1/2 lb) block, Keep Refrigerated under 40 degreesPotential contamination with E. coli O157:H7
- Class II
Food Recall · February 16, 2024
Chin Jung White Kimchi - 7 lb. 8 oz.(3.4 kg) plastic jarsUndeclared allergen; fish
- Class II
Food Recall · February 16, 2024
Chin Jung White Kimchi - 3 lb. 8 oz (1.58 kg) plastic jarsUndeclared allergen; fish
- Class II
Drug Recall · February 16, 2024
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc,Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
- Class II
Medical Device Recall · February 16, 2024
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CNeonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
- Class II
Drug Recall · February 16, 2024
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USStability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
- Class I
Food Recall · February 16, 2024
Raw Cheddar Cheese, made from unpasteurized milk, 8 oz (1/2 lb), shredded, in a plastic bag, Keep Refrigerated under 40 degreesPotential contamination with E. coli O157:H7
- Class III
Food Recall · February 16, 2024
The label reads, "Golden Sunrise Cold Pressured Juice Carrot, Orange, Pineapple, Lemon, Ginger & Turmeric 11 fl. oz."Bottle of juice was found at the store level with the incorrect sku label.
- Class II
Medical Device Recall · February 16, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060DLow concentration of sodium pyruvate in the wash could compromise gamete development
- Class II
Medical Device Recall · February 16, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090There is a potential for sterile package breach.
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS KitDue to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
- Class II
Medical Device Recall · February 15, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.
- Class II
Food Recall · February 15, 2024
Sekeroglu Lokum Love Turkish Delight With Pistachio And Pomegranate Flavor Double Roasted Delight 350 grams UPC:8683454050542. Packaged in a paper carton. 25 cartons per case.Product contains Acid Red 18
- Unclassified
Consumer Product Recall · February 15, 2024
Char-Broil LLC, of Columbus, Georgia
Digital Electric SmokersThe smokers can leak electrical current during use, posing an electric shock hazard.
- Class I
Drug Recall · February 15, 2024
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10Presence of Particulate Matter
- Class II
Food Recall · February 15, 2024
Sekeroglu Lokum Love Turkish Delight Mixed With Pistachio And Pomegranate Flavor Wrap Delight 350 grams UPC:8683454050627. Packaged in a paper carton. 25 cartons per case.Product contains Acid Red 18
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- Unclassified
Consumer Product Recall · February 15, 2024
Bell Sports Inc, of Irvine, California
Bell Soquel Youth HelmetsThe strap anchor can become dislodged from the helmet when sufficient force is applied, and therefore violates the CPSC federal safety regulation for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.
- Unclassified
Consumer Product Recall · February 15, 2024
FeraDyne Outdoors, LLC, of Superior, Wisconsin
Rhino 24-foot Hot Foot Climbing SticksThe climbing sticks can break at the weld point, posing fall and laceration hazards to consumers.
- Class III
Food Recall · February 15, 2024
Nicomex Tequesquite, Net Wt. 1.5oz (42.52gms), UPC: 8 8467810180 7. Packaged in a plastic bag.Elevated lead levels
- Class II
Medical Device Recall · February 15, 2024
SEASPINE ORTHOPEDICS CORPORATION
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050;Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
- Unclassified
Consumer Product Recall · February 15, 2024
BRS and BULin Liquid Fuel BottlesThe portable fuel bottles do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child-resistant, posing a risk of burn and poisoning to children. The 530mL BRS bottle was manufactured after the Portable Fuel Container Safety Act (PFCSA) became effective and lacks a flame mitigation device, posing a flash fire hazard.
- Unclassified
Consumer Product Recall · February 15, 2024
Electrolux Home Products, Inc. of Charlotte, North Carolina
Frigidaire rear-controlled rangesThe control panel (user interface) on the ranges can detach from the unit, posing electrical shock and electrocution hazards.
- Unclassified
Consumer Product Recall · February 15, 2024
Ocean State Jobbers Inc., of North Kingstown, Rhode Island
Calipso "Combi" and Tiller & Rowe "Growing Table-Mini Greenhouse and Raised Garden Bed"The recalled greenhouses can overheat, posing a fire hazard resulting in property damage and injury.
- Class II
Medical Device Recall · February 15, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- Class II
Medical Device Recall · February 14, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
- Class I
Food Recall · February 14, 2024
Jacksons Turkey and Cheese Sandwich, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983642601562. The sandwich label declares "Ingredients: Multigrain Bread ***ContainsUndeclared sesame.
- Class II
Food Recall · February 14, 2024
Jacksons Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983642541561.Potential cross contact with sesame.
- Class I
Food Recall · February 14, 2024
CK Turkey and Cheese Sandwich, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983644000141. The sandwich label declares "Ingredients: Multigrain Bread ***Contains: WheaUndeclared sesame.
- Class I
Food Recall · February 14, 2024
Woolery Enterprises, Inc. dba Will's Fresh Foods
Will's Fresh Foods Street Corn SaladL. mono contamination
- Class II
Food Recall · February 14, 2024
CK Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983644100032.Potential cross contact with sesame.
- Class II
Medical Device Recall · February 14, 2024
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
- Class II
Medical Device Recall · February 14, 2024
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-0Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
- Class II
Drug Recall · February 14, 2024
Golden State Medical Supply Inc.
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, CamarilloCGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- Class II
Medical Device Recall · February 14, 2024
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
- Class II
Medical Device Recall · February 14, 2024
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
- Class III
Food Recall · February 14, 2024
NAT & ART HAZELNUT TYPE FLAVOR #521510, in 6 gallon and "275" toteProduct was not made in accordance with formula