Safety Recalls
RSS ↗15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 6,401–6,450 of 15,271
- Class I
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG20009 Carrot, Shred; 12 poly bags per cardboard case; 18 lbs per casePotential to be contaminated with Listeria monocytogenes
- Class I
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG21002 Potato, Cooked Breakfast 2514111; 2514111B FG21002 Potato, Cooked Breakfast 2514311 Packaged 7- 4 lb polybags per cardboard casePotential to be contaminated with Listeria monocytogenes
- Class I
Food Recall · May 24, 2025
Atlantic Salmon Portions with Seafood Stuffing; 16 OZ (1 LB) 454g; Use/Freeze By: JUN.02.25; UPC: 4061459716313Atlantic Salmon Portions with Seafood Stuffing was incorrectly labeled and does not declare allergen ingredient (SOY)
- Class II
Medical Device Recall · May 23, 2025
SIGNA PET/MRGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class II
Medical Device Recall · May 23, 2025
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-HThis is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
- Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Class II
Medical Device Recall · May 23, 2025
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
- Class I
Medical Device Recall · May 23, 2025
Integra LifeSciences Corp. (NeuroSciences)
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.Lack of sterility assurance.
- Class II
Drug Recall · May 23, 2025
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDCFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
- Class II
Medical Device Recall · May 23, 2025
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instrumentDue to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
- Class II
Drug Recall · May 23, 2025
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDCFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
- Class II
Drug Recall · May 23, 2025
Consumer Product Partners, LLC
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
- Class II
Medical Device Recall · May 23, 2025
Discovery MR750w 3.0TGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class II
Medical Device Recall · May 23, 2025
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to downlInsulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.
- Class II
Food Recall · May 23, 2025
Comvita branded Manuka Honey + Lion's Mane for Focus; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001020Leaking induction seal on packaging.
- Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148BMedline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3)Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Class II
Medical Device Recall · May 23, 2025
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-5255Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
- Class II
Medical Device Recall · May 23, 2025
SIGNA ArchitectGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class II
Food Recall · May 23, 2025
Comvita branded Manuka Honey + Cordyceps for energy; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001037Leaking induction seal on packaging.
- Class II
Drug Recall · May 23, 2025
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2Presence of foreign tablets/capsules.
- Class II
Medical Device Recall · May 23, 2025
SIGNA Architect AIRGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class II
Food Recall · May 23, 2025
Comvita branded Manuka Honey + Reishi; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001013Leaking induction seal on packaging.
- Class II
Food Recall · May 23, 2025
Dr. Pepper, ZERO SUGAR, 12 FL OZ (355 mL) ALUMINUM CAN packaged and sold as 12 packs and 24 packs cartons cases. PRODUCED UNDER THE AUTHORITY OF CB Manufacturing Company, Inc., 5829 Pepsi Pl., JacksonProduct labeled to be Zero Sugar contains full sugar product.
- Class II
Medical Device Recall · May 22, 2025
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
- Class II
Medical Device Recall · May 22, 2025
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
- Class II
Medical Device Recall · May 22, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemo SoftwareDue to complaints, software update may cause software to unexpectedly shutdown.
- Class II
Medical Device Recall · May 22, 2025
Siemens Healthcare Diagnostics, Inc.
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
- Unclassified
Consumer Product Recall · May 22, 2025
Fujian Ming Jin Household Technology Limited, of China
Rolanstar 6-Drawer DressersThe recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the performance requirements of the STURDY Act because they can tip over with fewer than 60 pounds applied horizontally, and the dressers also fail to meet the labeling requirements of the STURDY Act.
- Unclassified
Consumer Product Recall · May 22, 2025
Anji Guyou Furniture Co. Ltd., of China
Sivan Six-Drawer Double DressersThe recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the performance requirements of the STURDY Act because they can tip over with fewer than 60 pounds applied horizontally, and the dressers also fail to meet the labeling requirements of the STURDY Act.
- Class II
Medical Device Recall · May 22, 2025
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
- Unclassified
Consumer Product Recall · May 22, 2025
Ningboyingpengdianzishangwuyouxiangongsi/YingPengStore, dba Nezmdi, of China
Nezmdi Baby SwingsThe swings pose a suffocation hazard and a risk of serious injury or death to babies, because they were marketed for infant sleep and have an incline angle greater than 10 degrees, in violation of the Safe Sleep for Babies Act. The swings also fail to meet the mandatory warning requirements under the swing regulations. In addition, the remote control included with the swings contains a lithium coin battery and is missing the required warnings and instructions for consumer products containing button cell and coin batteries under Reese's Law.
- Class II
Medical Device Recall · May 22, 2025
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
- Unclassified
Consumer Product Recall · May 22, 2025
Primark US Corp., of Boston, Massachusetts
DTR Plush Bag Stitch and DTR Plush Bag AngelThe zipper pull on the back of the plush bags can detach, posing a risk of serious injury or death from choking and/or ingestion of the zipper pull.
- Class II
Medical Device Recall · May 22, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemodynamics SoftwareDue to complaints, software update may cause software to unexpectedly shutdown.
- Class II
Drug Recall · May 22, 2025
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- Class I
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 15 CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Class I
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 8CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Class II
Medical Device Recall · May 22, 2025
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
- Class I
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator 8CM, Box of 1.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Unclassified
Consumer Product Recall · May 22, 2025
Macy's Merchandising Group Inc., of New York
Holiday Lane Infant Footed PajamasThe elastic on the pajamas' ankles can be too tight and restrict blood circulation, posing an injury hazard.
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Medical Device Recall · May 21, 2025
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release ConfDue to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
- Class I
Medical Device Recall · May 21, 2025
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HTVentilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class I
Drug Recall · May 21, 2025
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.