Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 12,401–12,450 of 15,379
- Class I
Food Recall · April 26, 2024
Gibson Farms Organic Nuts -Light Halves and PiecesPotential E. coli O157:H7 contamination.
- Class II
Food Recall · April 26, 2024
Jamai Bou CHADNI HOT MIX CHANACHUR, 300 g (10.5 oz) bag, UPC 8 904293 104129, 30 bags per wholesale caseVisible undeclared peanuts
- Class II
- Unclassified
Consumer Product Recall · April 25, 2024
Euromarket Designs Inc., d/b/a Crate & Barrel, of Northbrook, Illinois
Crate & Barrel Hampshire CribsThe recalled log splitter's hydraulic cylinder rod can separate from the piston, preventing the wedge from retracting. Reengaging the rod to the piston can cause the rod and wedge to move unexpectedly, posing injury hazards.
- Unclassified
Consumer Product Recall · April 25, 2024
3M Company, of Saint Paul, Minnesota
3M™ Peltor™ X4 Series EarmuffsThe recalled noise-reducing earmuffs can develop cracks in the colored portion of the plastic cups, posing a risk of overexposure to loud noise and sound.
- Unclassified
Consumer Product Recall · April 25, 2024
Chau River Sports Outdoors, of China
Kid's Bike HelmetsThe helmets do not comply with the dynamic strength of retention system, impact attenuation and certification requirements of 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 · April 25, 2024
Oregon Tool Inc., of Portland, Oregon
Oregon, PowerPro, Country Tuff, and Speeco branded log splitters and cylinder kitsThe recalled log splitter's hydraulic cylinder rod can separate from the piston, preventing the wedge from retracting. Reengaging the rod to the piston can cause the rod and wedge to move unexpectedly, posing injury hazards.
- Class II
Drug Recall · April 25, 2024
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC:Presence of Particulate Matter: Potential for black particulates in the drug product.
- Unclassified
Consumer Product Recall · April 25, 2024
Crosman Corp., of Bloomfield, New York
Crosman Icon Air RiflesAn uncocked and loaded air rifle can discharge unexpectedly if jolted or dropped, posing an injury hazard.
- Class II
Drug Recall · April 25, 2024
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, DistrDefective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
- Class III
Drug Recall · April 25, 2024
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
- Unclassified
Consumer Product Recall · April 25, 2024
JAKKS Pacific Inc., of Santa Monica, California
Mario Kart™ 24V Ride-On Racer CarsIf the acceleration pedal on the battery-operated ride-on toy becomes clogged with debris, it can stick after the user's foot is removed from the pedal, posing a crash hazard.
- Class II
Food Recall · April 25, 2024
Fresh N Lean brand Crustless Chicken Potato Pot Pie. Packaged in plastic trays, vacuum sealed.Possible contamination with Listeria monocytogenes
- Class II
Medical Device Recall · April 25, 2024
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx OnlyDue to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
- Class II
Medical Device Recall · April 25, 2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
- Class II
Drug Recall · April 24, 2024
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured byPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Class II
Medical Device Recall · April 24, 2024
Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 1The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.
- Class II
Medical Device Recall · April 24, 2024
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4Packaging contained the incorrect size of femoral head from what was displayed on the label.
- Class II
Drug Recall · April 24, 2024
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics,Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Unclassified
Consumer Product Recall · April 24, 2024
Sant and Abel, of Los Angeles, California
Sant and Abel Children's Two-Piece Pajama SetsThe children's pajamas fail to meet the flammability standards for children's sleepwear, posing a burn hazard to children.
- Class I
Food Recall · April 24, 2024
Queso de mano, Fresh soft white cheese, NET WT 24 oz.(640g), Keep Refrigerated, plastic container, packed 12 plastic containers of 24 oz per casePotential contamination with Listeria Monocytogenes
- Class II
Drug Recall · April 24, 2024
Coast Quality Pharmacy, LLC dba Anazao Health
Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.Presence of Foreign Substance; Broken metal piece found embedded in tablet.
- Class II
Medical Device Recall · April 24, 2024
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 1The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.
- Class III
Drug Recall · April 24, 2024
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06Subpotent drug
- Class II
Drug Recall · April 24, 2024
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured byPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Class II
Drug Recall · April 24, 2024
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 PrincetoDiscoloration: Dotted and yellow spots on tablets
- Class II
Medical Device Recall · April 24, 2024
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube displayWe have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.
- Class II
Drug Recall · April 24, 2024
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 PrincetoDiscoloration: Dotted and yellow spots on tablets
- Class II
Medical Device Recall · April 24, 2024
Olympus Corporation of the Americas
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displaysA subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
- Class II
Medical Device Recall · April 23, 2024
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
- Class II
Drug Recall · April 23, 2024
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403,CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
- Class II
Medical Device Recall · April 23, 2024
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
- Class II
Medical Device Recall · April 23, 2024
Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog:Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Trevo Trak 21 Microcatheter, Catalog: 90338Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Trevo ProVue, Catalog: 90184Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
DAC 044 115cm, Catalog: 90760Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.Some applicator tips from these lots had open seals.
- Class II
Medical Device Recall · April 23, 2024
Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125Quarantined product was inadvertently distributed
- Class II
Drug Recall · April 23, 2024
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403,CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
- Class II
Drug Recall · April 23, 2024
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
- Class II
Drug Recall · April 23, 2024
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown,Lack of Assurance of Sterility: Complaints of syringe breakage
- Class II
Medical Device Recall · April 23, 2024
Cascade IOMAX Cortical Module, REF: 190296-200There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
- Class II
Medical Device Recall · April 23, 2024
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STNeurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 22, 2024
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rateDuring the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
- Class II
Medical Device Recall · April 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
- Class I
Drug Recall · April 22, 2024
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.Marketed Without An Approved NDA/ANDA
- Class II
Medical Device Recall · April 22, 2024
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/AAlcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.