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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

13251–13275 of 13837

  • 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-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-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-2281-2021·2021-08-18

    Edwards PediaSat Oximetry Catheters Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.

    Product
    Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2234-2021·2021-08-18

    Medline Arthroscopy Kit Recalled for Expired Irrigation Component

    Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.

    Product
    Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2264-2021·2021-08-18

    Hip Implant Component Recalled for Fretting Corrosion Risk

    Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion that could lead to device failure and require surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
    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-2207-2021·2021-08-18

    Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities

    A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.

    Product
    Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2021·2021-08-18

    Biomet Hip Implant Cone Bodies Recalled Due to Fretting Corrosion Risk

    Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2021·2021-08-18

    Stryker Electric Hospital Beds Recalled for Unintended Home Use

    Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.

    Product
    Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
    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-2205-2021·2021-08-18

    Transport Stretcher 747 distributed to home users without professional training

    Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.

    Product
    Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2276-2021·2021-08-18

    Automated diagnostic analyzer from Abbott recalled for waste pressure buildup

    Abbott is recalling 260 Alinity s System analyzers due to a design defect allowing waste pressure to build up and spray operators. No injuries reported.

    Product
    Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2021·2021-08-18

    Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk

    Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk

    Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2243-2021·2021-08-18

    Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator

    Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.

    Product
    MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2021·2021-08-18

    Simpleware ScanIP Medical Software Recall: Incorrect Anatomical Orientation Display

    Simpleware ScanIP medical software may display anatomical orientation tags incorrectly, potentially causing surgical planning errors. This FDA Class II recall affects versions from 2018–2021 distributed in the US and internationally.

    Product
    Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
    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-2282-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Set recalled for potential internal leaks

    Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.

    Product
    Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
    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-2242-2021·2021-08-18

    Smith & Nephew Orthopedic Nail May Detach During Surgery

    Smith & Nephew is recalling an orthopedic surgical nail (BHR SQUARE HEADED, catalog #999908) that may detach during surgery. Forty-seven affected units have been distributed worldwide.

    Product
    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2021·2021-08-18

    Biomet Arcos Hip Implant Revision Bodies Recalled for Corrosion Risk

    Biomet is recalling specific Arcos hip implant components due to potential fretting corrosion of the inner taper that could lead to device failure and require surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2021·2021-08-18

    Bard Bone Marrow Aspiration Needles Recalled for Incomplete Packaging Seals

    Bard Peripheral Vascular is recalling Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles due to incomplete or open packaging seals that could compromise sterility. Approximately 1,200 devices are affected.

    Product
    TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2021·2021-08-18

    Stryker Prime Big Wheel Stretcher distributed to home users may lack professional-only guidance

    The Prime Big Wheel Stretcher was distributed to home users, but is intended for professional healthcare facility use only. Home users may not understand the professional-only instructions, creating safety risks.

    Product
    Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
    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