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

9951–9975 of 13717

HighFDA (Devices)·Z-1043-2023·2023-02-08
Biomet Vanguard Knee Implant Components Recalled for Incorrect Labeling
Biomet, Inc. is recalling specific Vanguard Knee System prosthetic components that are incorrectly labeled with wrong sizes and sides. This labeling error could result in incorrect implant placement during knee replacement surgery.
Product
(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left;
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1032-2023·2023-02-08
Non-sterile procedural trays with potential sterile packaging breach
Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.
Product
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2023·2023-02-08
Turbett Surgical Container TS1200 Recalled Due to Potential Weld Failures
Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.
Product
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2023·2023-02-08
Non-sterile procedural trays risk sterile packaging breach
Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.
Product
Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2023·2023-02-08
MEDLINE procedural trays recalled for potential sterile packaging breach
MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.
Product
Non-sterile procedural trays labeled as CRANI, 2 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1042-2023·2023-02-08
Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side
Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective surgery.
Product
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Num
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1044-2023·2023-02-08
Biopsy Medium for In Vitro Fertilization Recalled Due to Product Contamination
CooperSurgical is recalling a lot of Biopsy Medium used in IVF procedures because the product may contain an incorrect medium that could degrade embryos. No illnesses have been reported.
Product
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1039-2023·2023-02-08
Non-Invasive Patient Tracker Verification Failure During Image-Guided Surgery
Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.
Product
AxiEM" Non-Invasive Patient Tracker
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1028-2023·2023-02-08
Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall
Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.
Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2023·2023-02-08
Turbett Surgical Container TS1000 may have weld failures breaching sterile barrier
Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.
Product
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2023·2023-02-08
GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation
W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.
Product
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2023·2023-02-08
Procedural trays recalled for potential sterile packaging breach
Medline Industries recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.
Product
Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2023·2023-02-08
SynCardia Total Artificial Heart System Recalled for Cannula Tears
SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.
Product
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1041-2023·2023-02-08
Biopsy marker device recalled for label and contents mismatch
Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.
Product
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1049-2023·2023-02-08
Lucid TCD 2.0 Transcranial Ultrasound System Recalled for Hard Drive Failure
The Lucid TCD 2.0 System has a faulty hard drive that causes the device to freeze and reboot. Eventually, the system becomes completely inoperable.
Product
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1050-2023·2023-02-08
Ultrasound system hard drive defect causes device freezing and failure
FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.
Product
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0959-2023·2023-02-01
Getinge Flow-i Anesthesia Systems Recalled for Software Ventilation Defect
Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.
Product
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0960-2023·2023-02-01
Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation
The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.
Product
Getinge Flow-c Anesthesia System, Part No. 6887700
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0961-2023·2023-02-01
Getinge Flow-e Anesthesia System Software Defect Prevents Patient Ventilation
Getinge Flow-e Anesthesia System units with certain software versions contain a bug that can prevent pressure buildup and ventilation delivery. This may result in inadequate oxygen delivery and hypoxia in anesthesia patients.
Product
Getinge Flow-e Anesthesia System, Part No. 6887900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2023·2023-02-01
MyDay Toric and Reveal 1 Day Toric Contact Lenses Recalled for Incorrect Power
CooperVision is recalling MyDay Toric and Reveal 1 Day Toric contact lenses because some may have incorrect power, resulting in poor visual acuity. Consumers using affected lots should stop wearing the lenses and consult their eye care provider.
Product
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1015-2023·2023-02-01
Medical Device Manufacturer Recalls VAD Drive Kits With Expired Component
Medline Industries is recalling 1,050 kits of Centurion Medical Products Silver Antimicrobial VAD Drive due to expired components. Affected kits were distributed across New York, Indiana, Florida, New Jersey, and Illinois.
Product
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2023·2023-02-01
Siemens myNeedle Guide Software: Swapped Orientation Labels in CT Systems
Siemens myNeedle Guide software for CT imaging systems has swapped orientation labels in axial images, which could lead to misorientation during guided procedures. The software requires correction.
Product
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1005-2023·2023-02-01
Veritas Advanced Infusion Packs Recalled Due to Weld Gap Defect
Johnson & Johnson Surgical Vision is recalling Veritas Advanced Infusion Packs for a weld defect that may impair vacuum delivery during ophthalmic surgery. This could result in surgical delays and transient corneal swelling.
Product
Veritas Advanced Infusion Packs, REF: VRT-AI
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1008-2023·2023-02-01
COVID-19 diagnostic test kits recalled for specimen leakage risk
Meridian Bioscience is recalling 92 Revogene SARS-CoV-2 test kits due to potential specimen leakage from the cartridge, which could expose laboratory personnel to aerosolized COVID-19 virus.
Product
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2023·2023-02-01
Teleflex Endotracheal Tubes Recalled for Potential Cuff and Balloon Dysfunction
Teleflex is recalling approximately 497 endotracheal tubes worldwide due to potential failure of pilot balloon inflation or cuff deflation, which could interfere with airway management.
Product
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Inse
Category
Medical Device
Distribution
Distributed nationwide

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9951–9975 of 13717