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

Agency

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

23101–23125 of 40299

  • HighFDA (Devices)·Z-2527-2018·2018-08-01

    GE MR Surgical Suite Option Recalled for Patient Transfer Mechanism Defect

    GE Medical Systems is recalling 54 MR Surgical Suite Option units because a defect in the table transfer release may cause an unexpected loss of function in the patient transfer mechanism.

    Product
    MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2018·2018-08-01

    Roche Recalls cobas m 511 Hematology Analyzer for Discrepant Results

    Roche Diagnostics Hematology is recalling 17 cobas m 511 integrated hematology analyzers due to discrepant results in patients with severe microcytic anemia.

    Product
    cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2545-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Tissue Culture Medium Due to Seal Defect

    Life Technologies is recalling 91 units of Gibco DMEM tissue culture medium because compromised fill port seals may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2526-2018·2018-08-01

    Siemens Artis zee Systems Recalled for Defective Cooling Unit Seals

    Siemens is recalling Artis zee angiography systems with specific Laird cooling units due to defective seals that may allow coolant to leak into electrical parts, potentially causing sudden system shutdowns.

    Product
    Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2533-2018·2018-08-01

    Ethicon Recalls PDS Plus Antibacterial Sutures for Tensile Strength Defects

    Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.

    Product
    PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2547-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Cell Culture Medium Due to Seal Defect

    Life Technologies is recalling 70 units of Gibco DMEM cell culture medium because compromised fill port seals may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2536-2018·2018-08-01

    Bard Medical Recalls Arctic Sun Temperature Management Systems Due to Wiring Defect

    Bard Medical Division is recalling 5,608 Arctic Sun 5000 Temperature Management Systems because an improper wiring connection may cause overheating and component failure.

    Product
    Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of…
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2554-2018·2018-08-01

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to erroneous beam profile parameters that may cause incorrect dose calculations in large or off-axis fields.

    Product
    RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2018·2018-08-01

    Medela Invia Motion Negative Pressure Wound Therapy System Recalled for Battery Error

    Medela Inc is recalling 778 units of the Invia Motion Negative Pressure Wound Therapy System because the device may display a battery missing error.

    Product
    Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2018·2018-08-01

    Leica M320 Microscope Systems Recalled for Gas Spring Bracket Failure

    Leica Microsystems is recalling 8,564 M320 Microscope Systems because screws holding the gas spring bracket may fail, causing the optics carrier to drop.

    Product
    Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2556-2018·2018-08-01

    CryoLife Recalls BioGlue Spreader Tips Due to Labeling Error

    CryoLife, Inc. is recalling BioGlue Spreader Tips because incorrect labels were applied to the packaging, and some required components were missing from the boxes.

    Product
    BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2540-2018·2018-08-01

    OMNI Hip System Acetabular Inserts Recalled for Improper Labeling

    OMNIlife science Inc. is recalling 16 units of ApeX-LNK Acetabular Inserts due to improper labeling on internal packaging and patient labels.

    Product
    OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2018·2018-08-01

    Philips Healthcare Recalls UNIQ Systems Due to Shutter Position Reset Issue

    Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.

    Product
    UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2534-2018·2018-08-01

    Ethicon Recalls PDS II Sutures for Tensile Strength Deficiency

    Ethicon, Inc. is recalling 72 units of PDS II sutures because they do not meet tensile strength specifications.

    Product
    PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2523-2018·2018-08-01

    GE Healthcare Recalls Brivo XR385 Digital Radiographic Systems

    GE Healthcare is recalling 58 Brivo XR385 digital radiographic systems because placing weight on the detector can cause image artifacts, leading to patient exam retakes.

    Product
    Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2500-2018·2018-08-01

    Philips Centron Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2018·2018-08-01

    Abbott Recalls CardioMEMS Electronics Units Due to False Error Messages

    Abbott is recalling 2,521 CardioMEMS Patient and Hospital Electronics Units because they may display a false Error 5 message due to a configuration defect.

    Product
    CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2541-2018·2018-08-01

    Bio-Rad PR4100 Microplate Reader Recalled for Power Supply Connector Risk

    Bio-Rad is recalling 153 PR4100 Microplate Readers because the power supply connector can fit incompatible components, risking irreparable damage to the system.

    Product
    PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2550-2018·2018-08-01

    Terumo Tubing Pack Convenience Kit Recalled for Incorrect Expiration Date

    Terumo is recalling Tubing Pack Convenience Kits labeled with an incorrect expiration date of April 30, 2019.

    Product
    Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2530-2018·2018-08-01

    Human Design Medical Recalls Vivo 65 Ventilators Due to Firmware Issue

    Human Design Medical is recalling 45 Vivo 65 home ventilators because some devices have an unreleased version of the Firmware upgrade tool.

    Product
    Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2551-2018·2018-08-01

    ImplantDirect Dental Implants Recalled for Incorrect Vial Label Part Number

    Implant Direct Sybron Manufacturing is recalling 124 units of ImplantDirect dental implants because the main vial label lists an incorrect part number, although the cap label is correct.

    Product
    ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Devices)·Z-2529-2018·2018-08-01

    Nobel Biocare Multi-Unit Abutment Recalled for Missing Label Information

    Nobel Biocare is recalling 74 units of Multi-Unit Abutments because the product labels are missing the lot number, expiration date, and other required information.

    Product
    Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous…
    Category
    Medical Device
    Distribution
    Distributed nationwide