Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 11,901–11,950 of 15,364
- Class I
Food Recall · May 17, 2024
Irvington Seafood, Inc. dba ISF, Inc.
Irvington Seafood Jumbo Crab Meat packaged in 1 lb plastic cups. 40 lbs casesListeria monocytogenes identified in finished product testing.
- Class II
Drug Recall · May 17, 2024
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., BerkCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Class II
Food Recall · May 17, 2024
Once Upon a Farm Organic Plant-Rich Meal, Curried Carrots & Beans, 3.5 oz, packed in single serving flexible pouches. Product is distributed frozen and is Not-Ready-To-Eat. The end user must cook thePotential contamination with Listeria monocytogenes
- Class II
Food Recall · May 17, 2024
Product is MACARONI Salad, but the bottom container is mislabeled with the ingredients statement for COLESLAW. Product is refrigerated and packaged in a clear square container with 3 applied labels wUndeclared Wheat. Aldi Macaroni Salad was mislabeled as Coleslaw and Coleslaw label does not declare wheat. Macaroni (pasta) is visible through a clear plastic package.
- Class II
Medical Device Recall · May 17, 2024
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-16520641 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
- Class II
Medical Device Recall · May 17, 2024
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- Class III
Drug Recall · May 17, 2024
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViLabeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
- Class II
Medical Device Recall · May 17, 2024
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
- Class II
Medical Device Recall · May 17, 2024
Cascade IOMAX Cortical Module, REF: 190296-200Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
- Class I
Food Recall · May 17, 2024
Irvington Seafood, Inc. dba ISF, Inc.
Irvington Seafood Finger Crab Meat packaged in 1 lb plastic cups. 40 lbs casesListeria monocytogenes identified in finished product testing.
- Class II
Medical Device Recall · May 17, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. ThePotential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
- Class II
Medical Device Recall · May 17, 2024
Siemens Healthcare Diagnostics Inc
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
- Class I
Food Recall · May 17, 2024
Irvington Seafood, Inc. dba ISF, Inc.
Irvington Seafood Claw Crab Meat packaged in 1lb plastic cups. 40 lb casesListeria monocytogenes identified in finished product testing.
- Class I
Food Recall · May 17, 2024
Queso Chonero Special White Cheese UPC 7 861105 900496The product is positive for Listeria monocytogenes
- Class II
Medical Device Recall · May 17, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blaCranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- Class II
Medical Device Recall · May 17, 2024
Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- Class II
Medical Device Recall · May 16, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY GastrointestiDue to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
- Class I
Medical Device Recall · May 16, 2024
Inspire Model 3028, IV Implantable Pulse GeneratorThere is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
- Class II
Medical Device Recall · May 16, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
TourniKwik Tourniquet Set (CFN 79012)Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- Class III
Drug Recall · May 16, 2024
Zydus Pharmaceuticals (USA) Inc
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08Failed Impurities/Degradation Specifications.
- Class II
Food Recall · May 16, 2024
Breadman Jalapeno Cheese Bagels, plastic bag, 16ozUndeclared milk allergen
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- Class III
Drug Recall · May 16, 2024
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 6498Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
- Class III
Drug Recall · May 16, 2024
Zydus Pharmaceuticals (USA) Inc
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0Failed Impurities/Degradation Specifications.
- Unclassified
Consumer Product Recall · May 16, 2024
Electrolux Home Products Inc., of Charlotte, North Carolina
Frigidaire and Kenmore Smooth-top Freestanding Electric RangesDepending on the model, the surface heating elements can: 1) turn on spontaneously without being switched on; 2) fail to turn off after being switched off; or 3) heat to different temperatures than selected. This poses fire and burn hazards to consumers.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Food Recall · May 16, 2024
Breadman Raisin Bread, plastic bag, 16ozUndeclared milk allergen and undeclared Yellow No. 5
- Class I
Food Recall · May 16, 2024
Andersen & Sons Shelling, Inc.
Andersen & Sons Shelling, Inc. Macadamia Nuts, Dry Roasted Style 6 25 lbs.Listeria monocytogenes contamination
- Class II
Food Recall · May 16, 2024
Breadman Brioche products in plastic bags: Brioche Toast, 2 lb. (1 loaf/bag), Brioche Buns, 40oz (10 buns/bag), Brioche Sliders, 50oz (25 sliders/bag), Brioche Hot Dog, 40oz (10 buns/bag)Undeclared Yellow No. 5
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLYDeep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Fresenius Medical Care Holdings, Inc.
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
- Unclassified
Consumer Product Recall · May 16, 2024
Haikouhuidishangmaoyouxiangongsi, of China
CHZHVAN Combination Smoke and Carbon Monoxide DetectorsThe detectors can fail to activate, posing a risk that consumers will not be alerted to a fire.
- Unclassified
Consumer Product Recall · May 16, 2024
Kano Laboratories LLC, of Bohemia, New York
Super Lube Syncopen Synthetic Penetrant, Super Lube Fire Resistant Hydraulic Fluid, and Super Lube Metal Protectant and Corrosion Inhibitor (consumer sizes of five gallons or less)The recalled products contain either ethylene glycol or low-viscosity petroleum distillates, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging for the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children. Additionally, petroleum distillates can get into the lungs, causing chemical pneumonia and/or pulmonary damage, which can be fatal.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary andProduct labels state the incorrect expiration dates that extends beyond their true expiration date
- Class II
Medical Device Recall · May 15, 2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AGEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.