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

12176–12200 of 13837

HighFDA (Devices)·Z-0729-2022·2022-03-16
Vascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications
A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.
Product
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0738-2022·2022-03-16
FDA Recalls Diagnostic Test Strips for False Positive Results
NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.
Product
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2022·2022-03-16
Philips Allura Xper X-ray systems cooling system leak poses fire risk
Philips Allura Xper interventional X-ray systems may experience cooling liquid leaks that could drip on electrical components, creating risk of fire, smoke, or burning odors. No injuries have been reported.
Product
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2022·2022-03-16
Radiation therapy planning software displays wrong images during animation playback
RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.
Product
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Includi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0743-2022·2022-03-16
Medtronic endotracheal tubes recalled due to manufacturing nonconformity
Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.
Product
NIM TRIVANTAGE EMG Endotracheal Tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0747-2022·2022-03-16
Proton Therapy Systems May Fail to Verify Beam Range After Pause
Proton therapy systems from Ion Beam Applications may not verify that beam range settings remain unchanged after treatment pause, risking incorrect treatment delivery if the range was manually modified.
Product
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0727-2022·2022-03-16
B. Braun dispensing pins recalled for air filter leakage risk
B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.
Product
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2022·2022-03-16
Diagnostic Testing Plates Recalled for Inaccurate Antibiotic Susceptibility Results
Remel Inc is recalling 1210 Thermo Sensititre Gram Negative Testing Plates due to inaccurate susceptibility results that could affect antibiotic resistance testing.
Product
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0739-2022·2022-03-16
Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect
Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.
Product
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0744-2022·2022-03-16
PuraSinus Nasal Hemostat Recalled Due to Unvalidated Shipping Boxes
3-D Matrix, Inc. is recalling PuraSinus Absorbable Nasal Hemostat units because the shipping boxes used for transport were not validated.
Product
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0731-2022·2022-03-16
Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates
Celltrion USA Inc. is recalling 1.2 million DiaTrust COVID-19 rapid test kits due to incorrect expiration dates on packaging. The kits were distributed to 11 states.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0723-2022·2022-03-16
CIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation
Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 and 6000 AngioPlex devices. The optic nerve head angiography feature was distributed without FDA pre-market clearance and must be disabled.
Product
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0726-2022·2022-03-16
HeartWare HVAD System: Updated Cleaning Instructions for Power Connectors
Updated cleaning instructions are being provided for the HeartWare HVAD System's power connectors. Improper cleaning can remove protective lubricant required for proper power switching.
Product
HeartWare Ventricular Assist Device (HVAD) System
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0745-2022·2022-03-16
HeartSine Samaritan PAD Defibrillator Shipped Without Battery and Pads
Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.
Product
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0663-2022·2022-03-09
Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled
Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.
Product
Philips Respironics V60 Plus Ventilator Part Number 1138747
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-0680-2022·2022-03-09
Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use
Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0662-2022·2022-03-09
Philips V60 Ventilator Recall: Expired Adhesive May Cause Device Failure
A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.
Product
Philips Respironics V60 Ventilator Part Number 1053617
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-0659-2022·2022-03-09
COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results
Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0692-2022·2022-03-09
AU/DxC AU Magnesium Test Kits Recalled Due to Measurement Error in Lipemic Samples
Beckman Coulter is recalling 181,776 AU/DxC AU Magnesium test kits because the test may give falsely elevated results in lipemic samples, potentially affecting clinical interpretation.
Product
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0689-2022·2022-03-09
Titanium Toe Joint Implant Labeling Error: Unvalidated MRI Safety Claims
BioPro Titanium MPJ toe implants are recalled due to false documentation claiming MRI safety testing that was never performed. Patients should not undergo MRI with this implant until properly evaluated.
Product
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2022·2022-03-09
BUTLER Clear Dip Recalled for Lack of FDA Premarket Clearance
Sunstar Americas is recalling BUTLER Clear Dip nationwide due to lack of FDA premarket clearance. The product was distributed in 22,514 units across multiple lot codes.
Product
BUTLER Clear Dip, 12 bottles/case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0699-2022·2022-03-09
Helix Elite Molecular Reference Standard Recall for Failed Shelf-Life Testing
Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.
Product
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2022·2022-03-09
Surgical knee navigation implant recalled over sterilization failures
Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2022·2022-03-09
Digital Angiography System generator may exceed safe radiation dose rates
Shimadzu recalled 28 Digital Angiography Systems with Generator Model D150GC-40 due to inadequate installation adjustment criteria that may cause x-ray radiation dose rates to exceed safe fluoroscopic imaging limits.
Product
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0693-2022·2022-03-09
Regard TOTAL HIP surgical implant recalled due to incorrect product identification labeling
ROi CPS LLC is recalling 50 kits of Regard TOTAL HIP implants distributed in Missouri due to incorrect product identification labeling on individual kits. This mislabeling could result in the wrong implant being used in surgery.
Product
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Category
Medical Device
Distribution
0 states

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12176–12200 of 13837