Safety Recalls

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15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 8,751–8,800 of 15,362

Medical Device Recall · December 16, 2024
Integra LifeSciences Corp.
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hyd
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II
Drug Recall · December 16, 2024
SOMERSET THERAPEUTICS LLC
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Failed Impurities/Degradation Specifications
Class III
Drug Recall · December 16, 2024
SHOPPERS- PLAZA
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Class I
Drug Recall · December 16, 2024
FDC Limited
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II
Food Recall · December 16, 2024
Pinsarella Food LLC
Pinsarella Roman Pizza, POL127-24, UPC 6 08539 14655 0 -Oval, 12x7/ 7.0 Oz, Parbaked, 6 units per bag, 24 units per box., UPC 1 98715 69442 0 - Oval, 14x9/ 10.6 Oz, Parbaked, 6 units per bag, 24 units
Undeclared allergens (Wheat and Soy)
Class I
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Class II
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Class II
Medical Device Recall · December 15, 2024
Alphatec Spine, Inc.
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 d
Complaints have been received regarding post-operative implant collapse.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30
Potential for hole in package compromising sterility of the medical kit.
Class II
Food Recall · December 13, 2024
Frito Lay Inc
13 oz. Lay's Classic Potato Chips.
Undeclared Milk Allergen
Class I
Medical Device Recall · December 13, 2024
Hologic, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Descript
Potential for hole in package compromising sterility of the medical kit.
Class II
Drug Recall · December 13, 2024
Amerisource Health Services LLC
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-42
Presence of Foreign Tablets/Capsules
Class II
Food Recall · December 13, 2024
Horizon Organic Dairy, LLC
Horizon Organic Aseptic Plain Whole Milk 8OZ 12 Pack. Refrigerate after opening. With the following UPC: 3663207113 (12 pack); 3663207127 (single unit). Distributed by: Danone US, LLC Broomfield, CO
Potential for premature product spoilage during shelf life.
Class II
Food Recall · December 13, 2024
MR BING FOODS INC.
Mr. Bing brand Sriracha Chili Sauce; 9 oz and 18 oz, in clear PET bottle with green cap; UPC 850044819072 and UPC 850044819058
Product may contain spoilage organisms.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dress
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Vehicle Recall · December 12, 2024
General Motors, LLC
2025 CHEVROLET EQUINOX EV
A vehicle that fails to make sufficient sound may result in pedestrians being unaware of an approaching vehicle, increasing the risk of injury.
Unclassified
Food Recall · December 12, 2024
Shata Traders Inc.
THREE RIVERS brand TUTTI-FRUTTI; INGREDIENTS Papaya Cubes, Sugar, Citric Acid (E-330), Potassium Sorbate (E-202), FD&C Red #40, FD&C Blue #1, Curcumine #E-100, Annatto #E-160b; Imported & Distributed
Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.
Class II
Medical Device Recall · December 12, 2024
LivaNova USA, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Class II
Consumer Product Recall · December 12, 2024
PMI WW Brands LLC, dba Stanley 1913, of Seattle, Washington
Switchback and Trigger Action travel mugs
These mug's lid threads can shrink when exposed to heat and torque, causing the lid to detach during use, posing a burn hazard.
Unclassified
Medical Device Recall · December 12, 2024
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Class I
Food Recall · December 12, 2024
COREPACK MANUFACTURING INC
White Maeng da, kratom powder product packaged mylar resealable bags. 3 oz package, 80 bags per shipper box.
Possible Salmonella contamination of affected product.
Class I
Medical Device Recall · December 12, 2024
Abiomed, Inc.
Impella RP with SmartAssist; Product Number: 0046-0035;
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Drug Recall · December 12, 2024
Akron Pharma, Inc.
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Vehicle Recall · December 12, 2024
Chrysler (FCA US, LLC)
2024 JEEP GRAND CHEROKEE, 2024 JEEP GRAND CHEROKEE L
An improper air bag deployment can increase the risk of injury. A fuel leak can increase the risk of a fire.
Unclassified
Drug Recall · December 12, 2024
Akron Pharma, Inc.
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Drug Recall · December 12, 2024
Akron Pharma, Inc.
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Drug Recall · December 12, 2024
Akron Pharma, Inc.
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Drug Recall · December 12, 2024
Akron Pharma, Inc.
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Drug Recall · December 12, 2024
Buy-Herbal
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Class I
Drug Recall · December 12, 2024
Ascend Laboratories, LLC
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II
Drug Recall · December 12, 2024
Ascend Laboratories, LLC
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II
Drug Recall · December 12, 2024
Akron Pharma, Inc.
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Drug Recall · December 12, 2024
Akron Pharma, Inc.
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Drug Recall · December 12, 2024
GNMart LLC
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Class I
Consumer Product Recall · December 12, 2024
Mr. Christmas LLC, of Memphis, Tennessee
Wireless Decorative Tree Light Controllers
The wireless receiver that plugs into an outlet can overheat, posing a fire hazard.
Unclassified
Food Recall · December 12, 2024
WHOLESALE PRODUCE SUPPLY LLC DBA
Cucumbers, Wholesale Produce Supply, 752 Kasota Circle, Minneapolis, MN 554145. Product of Mexico. Cucumbers sold in the following pack sizes: 1. 5 lb. pack 2. 6 ct individual items per case.
Cucumbers may be contaminated with Salmonella.
Class I
Consumer Product Recall · December 12, 2024
Parke-Bell Ltd. Inc., dba Touch of Class, of Huntingburg, Indiana
Wall Teester Bed Crowns
The welded metal tabs used to mount the recalled bed crowns can weaken, causing the bed crown to fall from the wall onto consumers below, posing an injury hazard.
Unclassified
Medical Device Recall · December 12, 2024
LivaNova USA, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I