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.

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25651–25675 of 27686

  • HighFDA (Devices)·Z-0584-2014·2014-01-08

    Philips Essenta DR X-ray System C-arm Casting Recall

    Philips is recalling 424 Essenta DR stationary X-ray systems because the C-arm casting may loosen and fall.

    Product
    Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2014·2014-01-08

    Philips HeartStart MRx Defibrillators Recalled for Potential Shutdown

    Philips is recalling HeartStart MRx monitor/defibrillators because they may shut down without warning if exposed to elevated electromagnetic interference.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0602-2014·2014-01-08

    Integra Camino Advanced Monitor Recalled for Reversed Pressure Display

    Integra LifeSciences is recalling 275 Camino Advanced Monitors because a firmware error may display reversed systolic and diastolic intracranial pressure values.

    Product
    Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling 1,085 Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.

    Product
    Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0600-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage

    Asante Solutions is recalling Conset Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and delivering less insulin than intended.

    Product
    Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2014·2014-01-08

    Stryker S3 Med/Surg Bed Recall for Foot End Cover Damage

    Stryker is recalling S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.

    Product
    S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0534-2014·2014-01-01

    CareFusion Recalls Alaris PC Units Due to System Error Messages

    CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.

    Product
    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0531-2014·2014-01-01

    C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies

    C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.

    Product
    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2014·2014-01-01

    B. Braun IV Catheters Recalled for Missing Safety Clip

    B. Braun Medical is recalling 55,200 Introcan Safety IV Catheters because one lot may lack the anti-needlestick safety clip.

    Product
    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2014·2014-01-01

    Varian Eclipse Treatment Planning System Software Deficiency Recall

    Varian Medical Systems is recalling Eclipse Treatment Planning System software due to a defect that may cause Monitor units to change unexpectedly during dose parameter adjustments.

    Product
    Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0556-2014·2014-01-01

    McKesson Radiology 12.0 PACS Recall for Missing Contrast Allergy Data

    McKesson Information Solutions LLC is recalling McKesson Radiology 12.0 PACS because merging patient records may result in missing contrast allergy information.

    Product
    McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0581-2014·2014-01-01

    Smith & Nephew Recalls Reflection Acetabular Liners Due to Tolerance Issues

    Smith & Nephew is recalling 38 units of Reflection acetabular liners because they may be out of tolerance and fail to fully seat into the shell.

    Product
    REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0578-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0580-2014·2014-01-01

    EOS Imaging Recalls steroEOS Workstation Due to Data Copying Error

    EOS Imaging is recalling 36 steroEOS Workstation units because a software error may prevent 3D model data from copying to clinical files and reports.

    Product
    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2014·2014-01-01

    Philips HeartStart MRx Defibrillator Recall for EtCO2 Display Error

    Philips is recalling HeartStart MRx defibrillators because they display a question mark instead of a value when patient CO2 levels fall below 7.6 mmHg.

    Product
    Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0572-2014·2014-01-01

    Trinity Biotech Recalls Captia Syphilis-G Test Kits Due to False Negatives

    Trinity Biotech is recalling Captia Syphilis-G Test Kits because they may produce false negative results for syphilis antibodies.

    Product
    Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum (…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2014·2014-01-01

    Stryker Orthopaedics Ball Impactor Tip Recalled for Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling Ball Impactor Tips used in surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2014·2014-01-01

    Stryker Orthopaedics Recalls Rim Impactor Tips Due to Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling 1,690 Rim Impactor Tips used in MDM surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2014·2014-01-01

    Siemens Dimension Chemistry Wash Recalled for Result Shifts

    Siemens is recalling Dimension Chemistry Wash lots that may cause shifts in QC and patient sample results for specific tests.

    Product
    Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0488-2014·2013-12-25

    Nephros SafeShower and SafeSpout Water Filters Recalled for Marketing Violations

    Nephros Inc. is recalling SafeShower and SafeSpout water filters because promotional materials marketed them as medical devices.

    Product
    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and…
    Category
    Medical Device
    Distribution
    Distributed nationwide