The Recall Desk

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.

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13301–13325 of 13837

  • HighFDA (Devices)·Z-2283-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Set: Potential Internal Leak Risk

    Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks that could affect proper device function.

    Product
    Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2214-2021·2021-08-18

    S3 MedSurg hospital beds recalled from residential sale due to misuse risk

    Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.

    Product
    S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2021·2021-08-18

    Codman Raney Scalp Clips recalled for compromised sterile barrier packaging

    Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.

    Product
    CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2021·2021-08-18

    Arcos Hip System Cones Recalled for Potential Inner Taper Corrosion

    Biomet recalled 11 Arcos Modular Revision Hip System proximal cones due to potential inner taper fretting corrosion and device failure that could require surgical intervention. Affected units distributed nationwide.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2021·2021-08-18

    Symmetry Plus Treatment Recliner distributed to home users instead of healthcare facilities

    A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.

    Product
    Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2021·2021-08-18

    Medical device designed for healthcare professionals distributed to untrained home users

    Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.

    Product
    ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2021·2021-08-18

    Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities

    Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.

    Product
    CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2021·2021-08-18

    Hip Implant Component Recalled Due to Potential Fretting Corrosion and Device Failure

    Biomet is recalling hip replacement components that could develop fretting corrosion and fail inside the body, potentially requiring revision surgery.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2021·2021-08-18

    Michael Graves Stryker Highback Chair distributed to home users instead of healthcare facilities

    Stryker Medical Division recalled its Michael Graves Highback Chair (Model 4853) after it was distributed to residential customers instead of healthcare facilities. Home users may not understand safety instructions written for trained medical professionals.

    Product
    Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2021·2021-08-18

    Covidien Sonicision Surgical Generator Recalled for Manufacturing Defect Risk

    Covidien recalls 96 units of its Sonicision Reusable Generator surgical device due to a manufacturing assembly error that may cause device malfunction, thermal burns, or tissue damage. The defect may also disable the audio indicator that signals device activation.

    Product
    Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2021·2021-08-18

    Stryker IsoGel Air Medical Device Distributed to Home Users Instead of Healthcare Facilities

    Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.

    Product
    IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2021·2021-08-18

    Beckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk

    Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.

    Product
    ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2021·2021-08-18

    Dutch Ophthalmic Vitrectomy Pack Contains Mismatched Infusion Line Gauge

    Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.

    Product
    The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kits Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2261-2021·2021-08-18

    Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk

    Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2021·2021-08-18

    Hip Implant Component Failure Risk From Inner Taper Fretting Corrosion

    Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2021·2021-08-18

    Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination

    Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.

    Product
    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2021·2021-08-18

    Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers

    Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.

    Product
    Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2021·2021-08-18

    Hospital Bed Model 3005 Recalled for Distribution to Home Residents

    Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.

    Product
    S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2021·2021-08-18

    MYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly

    BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.

    Product
    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2209-2021·2021-08-18

    Prime TC Transport Chair Recalled for Improper Residential Distribution

    The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.

    Product
    Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2215-2021·2021-08-18

    Support Surface Device Distributed to Home Patients Without Healthcare Professional Instructions

    An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.

    Product
    Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2227-2021·2021-08-18

    CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance

    Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.

    Product
    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-2210-2021·2021-08-18

    InTouch 2131 Medical Device Recalled for Distribution to Residential Users

    Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.

    Product
    InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide