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

24776–24800 of 27722

  • SevereFDA (Devices)·Z-2192-2014·2014-08-27

    FDA Recalls Gel-E Donut and Squishon Baby Pillows Due to Mold

    Childrens Medical Ventures is recalling Gel-E Donut and Squishon 2 gel pillows because of visible mold. The mold was identified as Cladosporium and Penicillium fungi.

    Product
    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2148-2014·2014-08-27

    DePuy Synthes Recalls Craniomaxillofacial Distraction System Due to Reversal Risk

    Synthes, Inc. is recalling specific lots of the DePuy Synthes Craniomaxillofacial Distraction System because the devices may reverse after surgery.

    Product
    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2256-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2014·2014-08-27

    GE Healthcare Recalls Discovery XR656P/N Wall Stand Systems Due to Hook Failure

    GE Healthcare is recalling 334 Discovery XR656P/N wall stand systems because nylon hooks supporting the detector may fail, causing the detector to fall.

    Product
    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-2260-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2014·2014-08-27

    Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

    Zimmer, Inc. is recalling 190 non-sterile Persona Tibial General Instrument Trays because a geometry defect may prevent proper sterilization of included drill guides.

    Product
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2240-2014·2014-08-27

    TomoTherapy H Series Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2014·2014-08-27

    TomoTherapy Hi-Art Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1, and 1.2.2 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2014·2014-08-27

    ICU Medical Recalls Port Access Kits with Potential Sterility Issues

    ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.

    Product
    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2014·2014-08-27

    Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers

    Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.

    Product
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2296-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints about breakage. The recall covers corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2014·2014-08-27

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 601 units of Trigen Intertan nails because a manufacturing error caused the proximal lag screw hole to be positioned incorrectly.

    Product
    TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2014·2014-08-27

    ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals

    ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2014·2014-08-27

    Ortho Development Recalls Pivot Bipolar Cups Due to Sealing Defects

    Ortho Development is recalling Pivot Bipolar Cups because foil pouches failed to seal properly, allowing air to enter and potentially degrading the implant material.

    Product
    Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2014·2014-08-27

    Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

    Zimmer, Inc. is recalling 190 units of Persona Tibial General Instrument Trays because incorrect bracket geometry may prevent proper sterilization of surgical instruments.

    Product
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2238-2014·2014-08-27

    Siemens Dimension Chemistry Wash Recalled for Inaccurate Test Results

    Siemens Healthcare Diagnostics is recalling Dimension Chemistry Wash lot RD41041 because it caused accuracy shifts in specific patient and QC test results.

    Product
    Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints of breakage. This is a retrospective recall covering corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Seals

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Components Due to Breakage Complaints

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

    Product
    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling specific Uni*Fuse Infusion Systems because they may contain a guidewire that is too long. The recall covers 36 units distributed in the US and internationally.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2014·2014-08-27

    FDA Recalls Apex Arc Hip Stem Devices Due to Surface Staining

    Omnilife Science Inc. is recalling 13 Apex Arc Hip Stem devices due to staining on the implant surface.

    Product
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2245-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed a leak test due to damage of the inner cavity.

    Product
    Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2259-2014·2014-08-27

    Medtronic Recalls Six Activa PC Implantable Neurostimulators

    Medtronic is recalling six Activa PC implantable neurostimulators due to a potential manufacturing defect in an electrical component.

    Product
    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2252-2014·2014-08-27

    Philips IntelliSpace PACS 4.4 Software Recall for Data Integrity Issues

    Philips is recalling IntelliSpace PACS 4.4 software because a defect may cause incomplete patient data to be exported, potentially affecting diagnosis.

    Product
    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2293-2014·2014-08-27

    ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues

    ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.

    Product
    CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide