Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

12676–12700 of 13802

HighFDA (Devices)·Z-0188-2022·2021-11-10
FDA Recalls 3M Red Dot ECG Monitoring Electrodes Due to Potential Carbon Stud Breakage
3M Red Dot ECG monitoring electrodes (Catalog No. 2244) are being recalled due to potential breakage of the carbon stud from the eyelet. Approximately 2,081,000 units distributed nationwide and internationally are affected.
Product
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0184-2022·2021-11-10
Flexible Intubation Videoscope Recall Due to Sterility Assurance Failure
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
Product
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0197-2022·2021-11-10
Dental implants recalled for size mismatch with package labeling
Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.
Product
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0193-2022·2021-11-10
Siemens Aptio Interface Module may misassociate laboratory test results
Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.
Product
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0196-2022·2021-11-10
ADVIA Centaur SARS-CoV-2 Antigen Assay Recalled for Insufficient Validation Data
Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.
Product
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2022·2021-11-10
Arietta 65 Ultrasound Software: Calculation Error in EROA Diagnostic Measurements
Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.
Product
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2022·2021-11-10
Arietta 850 Ultrasound Software Displays Cardiology Measurements Incorrectly
FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.
Product
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2022·2021-11-10
MEDRAD Twist & Go Syringe Recalled Due to Labeling Error
Bayer Medical Care is recalling 6,950 units of MEDRAD Twist & Go Disposable Syringes due to labeling errors that could cause confusion about syringe compatibility with the MEDRAD Mark 7 Arterion Injection System.
Product
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0186-2022·2021-11-10
Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band
Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.
Product
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0185-2022·2021-11-10
Flexor Check-Flo Introducer recalled for misplaced radiopaque marker
Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.
Product
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0202-2022·2021-11-10
Aspiration Syringe Kit MVSK60 Inadvertently Shipped with OUS Labeling
MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.
Product
Aspiration Syringe Kit, REF: MVSK60
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0201-2022·2021-11-10
Medtronic Neuromodulation Clinician Programmer Application Software Anomaly Recall
Medtronic recalled the Clinician Programmer Application (CPA) model A610 due to a potential software anomaly. Affected versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081 have been distributed worldwide. No illnesses or injuries have been reported.
Product
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0118-2022·2021-11-03
Surgical Brain Guidance System Recalled for Inaccurate Electrode Placement
ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.
Product
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0179-2022·2021-11-03
BD Syringe Tip Cap Packaging Defect May Compromise Sterility
Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.
Product
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0175-2022·2021-11-03
Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results
AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.
Product
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2022·2021-11-03
ASC PneumoLiner surgical device recalled due to manufacturing orientation defect
Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.
Product
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, cons
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2022·2021-11-03
Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
Product
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2022·2021-11-03
GORE CARDIOFORM Septal Occluder devices labeled with incorrect expiration date
W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.
Product
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0001-2022·2021-11-03
RAPTAR Laser Range Finders Recalled for Field Modification Safety Risk
Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.
Product
RAPTAR Laser Range Finders
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2022·2021-11-03
GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.
Product
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0178-2022·2021-11-03
Bivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.
Product
Bivona Uncuffed Wire Endotracheal Tubes,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2022·2021-11-03
Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date
W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.
Product
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0177-2022·2021-11-03
Bivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.
Product
Bivona Aire-Cuf Endotracheal Tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0182-2022·2021-11-03
Brachytherapy Planning Software Dose Calculation Discrepancy
Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.
Product
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0171-2022·2021-11-03
Septal Occluder Devices Recalled for Incorrect Expiration Date Label
W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.
Product
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
Category
Medical Device
Distribution
47 states

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12676–12700 of 13802