Safety Recalls

15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 14,551–14,600 of 15,379

• Medical Device Recall · December 13, 2023

  Maquet Cardiovascular, LLC

  Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

  Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.

  Class I

• Food Recall · December 12, 2023

  Win Luck Trading Inc

  Tasty Snacks Plum Queen Dried Plums Net Weight 200G (7OZ) Packaged in cans. 30 cans per case.

  Undeclared sulfites

  Class II

• Medical Device Recall · December 12, 2023

  Johnson & Johnson Surgical Vision, Inc.

  TECNIS Toric II OptiBlue IOL Models ZCW

  Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.

  Class II

• Medical Device Recall · December 12, 2023

  Steris Corporation

  Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

  Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

  Class II

• Medical Device Recall · December 12, 2023

  Percussionaire Corporation

  High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

  Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user

  Class I

• Vehicle Recall · December 12, 2023

  Tesla, Inc.

  2023 TESLA MODEL 3

  In certain circumstances when Autosteer is engaged, and the driver does not maintain responsibility for vehicle operation and is unprepared to intervene as necessary or fails to recognize when Autosteer is canceled or not engaged, there may be an increased risk of a crash.

  Unclassified

• Drug Recall · December 12, 2023

  GlaxoSmithKline LLC

  ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869

  Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

  Class III

• Medical Device Recall · December 12, 2023

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M2

  System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

  Class II

• Medical Device Recall · December 12, 2023

  Greiner Bio-One North America, Inc.

  VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

  Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.

  Class II

• Medical Device Recall · December 12, 2023

  Steris Corporation

  Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754

  Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

  Class II

• Medical Device Recall · December 11, 2023

  Olympus Corporation of the Americas

  Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044

  The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

  Class II

• Drug Recall · December 11, 2023

  Legacy Pharmaceutical Packaging LLC

  Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packagin

  CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

  Class II

• Medical Device Recall · December 11, 2023

  Globus Medical, Inc.

  Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

  Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

  Class II

• Medical Device Recall · December 11, 2023

  Getinge Usa Sales Inc

  Flow-i C40 Anesthesia System, model 6677400

  Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

  Class II

• Medical Device Recall · December 11, 2023

  Globus Medical, Inc.

  Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S

  Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

  Class II

• Medical Device Recall · December 11, 2023

  RONAN MEDICAL LLC

  BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control

  Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.

  Class II

• Medical Device Recall · December 11, 2023

  Getinge Usa Sales Inc

  Flow-e Anesthesia System, model 6887900

  Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

  Class II

• Medical Device Recall · December 11, 2023

  Getinge Usa Sales Inc

  Flow-c Anesthesia System, model 6887700

  Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

  Class II

• Medical Device Recall · December 11, 2023

  Getinge Usa Sales Inc

  Flow-i C20 Anesthesia System, model 6677200

  Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

  Class II

• Medical Device Recall · December 11, 2023

  Globus Medical, Inc.

  Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S

  Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

  Class II

• Medical Device Recall · December 11, 2023

  Ethicon Endo-Surgery Inc

  ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No.

  There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.

  Class II

• Medical Device Recall · December 11, 2023

  Getinge Usa Sales Inc

  Flow-i C30 Anesthesia System, model 6677300

  Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

  Class II

• Vehicle Recall · December 10, 2023

  General Motors, LLC

  2023 CADILLAC LYRIQ

  Without external warning sounds, pedestrians may be unaware of an approaching vehicle, increasing the risk of a crash.

  Unclassified

• Vehicle Recall · December 10, 2023

  Southeast Toyota Distributors, LLC

  2023 TOYOTA 4RUNNER

  An overloaded vehicle increases the risk of a crash.

  Unclassified

• Vehicle Recall · December 10, 2023

  General Motors, LLC

  2023 GMC ACADIA, 2024 CADILLAC XT5, 2024 CADILLAC XT6

  A windshield that is not properly bonded may detach during a crash and increase the risk of injury.

  Unclassified

• Medical Device Recall · December 8, 2023

  Baxter Healthcare Corporation

  XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-5

  Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

  Class II

• Medical Device Recall · December 8, 2023

  Megadyne Medical Products, Inc.

  Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus

  Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

  Class I

• Food Recall · December 8, 2023

  Valley View Candies dba

  Maple Nut Fudge, 8oz, packaged in clear, plastic clamshell.

  Undeclared egg

  Class I

• Medical Device Recall · December 8, 2023

  Baxter Healthcare Corporation

  XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KI

  Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

  Class II

• Medical Device Recall · December 8, 2023

  Olympus Corporation of the Americas

  Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around

  Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

  Class II

• Medical Device Recall · December 8, 2023

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

  Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.

  Class II

• Medical Device Recall · December 8, 2023

  WAVi Co.

  WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporat

  Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

  Class II

• Food Recall · December 8, 2023

  Sweet Shop Candies, Inc

  Neiman Marcus Christmas Petit Fours 24pc

  mold and yeast in product

  Class II

• Food Recall · December 8, 2023

  Valley View Candies dba

  Chocolate Walnut Fudge, 8oz, packaged in clear, plastic clamshell.

  Undeclared egg

  Class I

• Medical Device Recall · December 8, 2023

  Megadyne Medical Products, Inc.

  Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode

  Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

  Class I

• Medical Device Recall · December 8, 2023

  Megadyne Medical Products, Inc.

  Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord

  Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

  Class I

• Medical Device Recall · December 8, 2023

  Baxter Healthcare Corporation

  Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT

  Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

  Class II

• Food Recall · December 8, 2023

  Valley View Candies dba

  Peanut Butter Fudge, 8oz, packaged in clear, plastic clamshell.

  Undeclared egg

  Class I

• Drug Recall · December 8, 2023

  Azurity Pharmaceuticals, Inc.

  Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1

  Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.

  Class III

• Food Recall · December 8, 2023

  Valley View Candies dba

  Chocolate Fudge, 8oz, packaged in clear, plastic clamshell.

  Undeclared egg

  Class I

• Medical Device Recall · December 8, 2023

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

  Loss of connectivity between the FlexArm and the Table due to a software issue.

  Class II

• Medical Device Recall · December 8, 2023

  Megadyne Medical Products, Inc.

  Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus

  Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

  Class I

• Vehicle Recall · December 7, 2023

  Nova Bus (US) Inc.

  2023 NOVA BUS LFS

  A sudden loss of drive power can increase the risk of a crash. Additionally, a disabled bus may require an evacuation procedure in an uncontrolled traffic situation, increasing the risk of injury to passengers.

  Unclassified

• Vehicle Recall · December 7, 2023

  Nova Bus (US) Inc.

  2023 NOVA BUS LFS

  Sudden loss of power steering assist can increase the risk of a crash.

  Unclassified

• Medical Device Recall · December 7, 2023

  Globus Medical, Inc.

  ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

  A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

  Class I

• Food Recall · December 7, 2023

  Herold Salads, Inc.

  Herold's Salad - Pasta Potpourri packaged in 1lb, 2lb, and 5lb plastic containers

  Potential contamination with Listeria monocytogenes

  Class I

• Medical Device Recall · December 7, 2023

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

  During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

  Class II

• Food Recall · December 7, 2023

  Herold Salads, Inc.

  Herold's Salad - Original Potato Salad packaged in 12oz, 1lb, 2lb, and 5lb plastic containers

  Potential contamination with Listeria monocytogenes

  Class I

• Food Recall · December 7, 2023

  Herold Salads, Inc.

  Herold's Salads - Cheddar Mac & Sour Cream packaged in 12oz, 1lb, 2lb, and 5lb plastic containers

  Potential contamination with Listeria monocytogenes

  Class I

• Food Recall · December 7, 2023

  Herold Salads, Inc.

  Herold's Salad - Original Potato Salad with egg packaged in 8oz, 1lb, 2lb, 5lb, and 10lb plastic containers

  Potential contamination with Listeria monocytogenes

  Class I