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 the agency’s own highest classification or reported deaths or serious injuries, 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

21501–21525 of 27663

  • HighFDA (Devices)·Z-1868-2016·2016-06-08

    Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling specific Laparotomy Packs because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2016·2016-06-08

    ConMed Recalls Hip Preservation System PreBent Burs Due to Metal Shavings

    ConMed is recalling 991 Hip Preservation System PreBent Burs because an assembly error caused metal shavings to be released during use.

    Product
    Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2016·2016-06-08

    Elekta Monaco RTP System Recalled for Treatment Planning Error

    Elekta is recalling Monaco RTP System software versions 5.10.00 and higher because a specific export setting causes incorrect jaw positioning in radiation therapy plans.

    Product
    Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2016·2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi Surgical System cannula seals because particulates could enter the cannula lumen during surgery.

    Product
    SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1871-2016·2016-06-08

    Skytron Monitor Bracket Recalled for Weld Failure Risk

    Skytron is recalling 24 Ergon III Series monitor brackets because a weld failure could cause the display to fall and injure users.

    Product
    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1870-2016·2016-06-08

    Windstone Medical Recalls General Surgery Packs with Medtronic Sponges

    Windstone Medical Packaging is recalling General Surgery Packs containing Medtronic Kerlix sponges due to potential sterile barrier compromise at the packaging seal.

    Product
    General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2016·2016-06-08

    Windstone Medical Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling 40 units of Laparotomy Pack Latex Free (part number 007725-7) because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2016·2016-06-08

    Fujifilm ED-250XT5 Endoscope Manual Recall Due to Bacteria Reports

    Fujifilm Medical Systems is recalling 882 ED-250XT5 endoscope operations manuals following reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2016·2016-06-08

    Fujifilm ED-450XT5 Endoscope Manual Correction for Infection Risk

    Fujifilm Medical Systems is correcting the ED-450XT5 endoscope manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2016·2016-06-08

    Miltex Chisel Blade Handle Recall Due to Insecure Blade Fit

    Integra York PA, Inc. is recalling Miltex Premium Grade Self-Lock Chisel Blade Handles because a wider slot may prevent the blade from securing firmly.

    Product
    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2016·2016-06-08

    Siemens Dimension Vista 1500 Lab System Software Defect Recall

    Siemens is recalling Dimension Vista 1500 systems due to a software defect that may cause the device to omit a rinse step, potentially leading to discrepant patient results.

    Product
    Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2016·2016-06-08

    Sterilmed Recalls Reprocessed Microline Scissor Tips Due to Manufacturing Defect

    Sterilmed is recalling 11,326 reprocessed Microline Scissor Tips due to a potential manufacturing defect that could result in patient injury.

    Product
    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1885-2016·2016-06-08

    Siemens Dimension Vista 500 Lab System Software Defect Recall

    Siemens recalls Dimension Vista 500 systems due to a software defect that may omit probe rinses, potentially causing discrepant patient results.

    Product
    Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2016·2016-06-08

    Smiths Medical Recalls CADD Administration Sets with Flow Stop

    Smiths Medical is recalling CADD Administration Sets with Flow Stop because under-delivery of medication may occur. The recall affects 13,696,830 units distributed in the US and internationally.

    Product
    CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1836-2016·2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.

    Product
    SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1880-2016·2016-06-08

    Ventlab STAT-Check Resuscitation Bag Recall Due to Non-Functional CO2 Indicators

    Ventlab LLC is recalling STAT-Check Resuscitation Bags because the carbon dioxide indicators are non-functional and fail to change color during use.

    Product
    STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2016·2016-06-08

    Fujifilm ED-530XT Endoscope Manual Correction for Infection Control

    Fujifilm Medical Systems is correcting the ED-530XT endoscope manual to address reports of multi-drug resistant bacteria found on endoscopes used in ERCP procedures.

    Product
    Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2016·2016-06-08

    Skytron EZ Slide Operating Table Recalled for Potential Slide Cap Detachment

    Skytron is recalling 458 EZ Slide Operating Tables because incorrectly manufactured parts may cause the slide cap to detach, risking injury to patients or staff.

    Product
    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2016·2016-06-08

    Fujifilm ED-250XL5 Endoscope Manual Correction for Infection Control

    Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2016·2016-06-08

    Greatbatch Medical Recalls Torque Limiting Devices Due to Sterility Failure

    Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.

    Product
    Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1882-2016·2016-06-08

    Greatbatch Medical Recalls Torque Limiting Handles Due to Sterility Failure

    Greatbatch Medical is recalling torque limiting handles because laboratory testing showed they do not meet required sterility levels after steam sterilization.

    Product
    Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1884-2016·2016-06-08

    Greatbatch Recalls Torque Limiting Devices Due to Sterility Assurance Failure

    Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.

    Product
    Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1850-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2016·2016-06-08

    Natus Medical Recalls Replacement HEPA Filters for Sterile-Driers

    Natus Medical is recalling 21 replacement HEPA filters for Sterile-Driers because improperly cured sealant may emit toxic gas or drip, contaminating the device.

    Product
    Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
    Category
    Medical Device
    Distribution
    18 states