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

25476–25500 of 40357

  • HighFDA (Devices)·Z-0172-2018·2017-12-06

    Brainlab ExacTrac Vero Radiation Therapy System Recall for Positioning Error

    Brainlab is recalling ExacTrac Vero systems because a software error may cause the treatment couch to miss the planned position, potentially affecting radiation therapy accuracy.

    Product
    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0174-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Control Recalled for Inaccurate Ceruloplasmin Assignment

    Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control lots due to inaccurate ceruloplasmin assignment, which may cause patient results to fall below the reference range.

    Product
    Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2018·2017-12-06

    Volcano Imaging Systems Recalled Due to Unexpected Windows Security Dialog

    Volcano Corporation is recalling specific intravascular ultrasound imaging systems because an unexpected Microsoft Windows Security dialog may appear during use, potentially affecting device operation.

    Product
    Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2018·2017-12-06

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2018·2017-12-06

    Arrow PICC Kits Recalled for Potential Incorrect Sheath Size

    Arrow International is recalling specific PICC kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0183-2018·2017-12-06

    BD Insulin Syringes Recalled for Incorrect Needle Length Labeling

    Becton Dickinson is recalling specific lots of BD Insulin Syringes because some polybags were mislabeled with the wrong needle length and gauge.

    Product
    BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2018·2017-12-06

    Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration

    CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.

    Product
    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0173-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Calibrator Recalled for Inaccurate Ceruloplasmin Results

    Siemens is recalling Dimension Vista Protein 1 Calibrators because they may produce inaccurate ceruloplasmin results below the reference range.

    Product
    Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2018·2017-12-06

    Arrow International Recalls Pressure Injectable PICC Kits Due to Sheath Error

    Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable PICC kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr sheaths.

    Product
    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2018·2017-12-06

    Zimmer Biomet Recalls Two Rosa Spine Stereotaxic Devices for Software Bugs

    Zimmer Biomet is recalling two Rosa Spine 1.0.2 devices worldwide to resolve software bugs and improve stability.

    Product
    Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0191-2018·2017-12-06

    Siemens N/T Protein Control SL Recalled for Inaccurate Ceruloplasmin Values

    CSL Behring GmbH is recalling Siemens N/T Protein Control SL products because they were incorrectly value-assigned, leading to biased ceruloplasmin test results.

    Product
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0179-2018·2017-12-06

    Arrow VPS Access Kit Recalled for Potential Size Mismatch

    Arrow International is recalling VPS Access Kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0185-2018·2017-12-06

    Implant Direct Legacy Dental Implants Recalled for Packaging Defect

    Implant Direct Sybron Manufacturing is recalling 75 units of Legacy 3 Dental Implants because a packaging defect may compromise sterilization.

    Product
    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2018·2017-12-06

    Arrow PICC Recall Due to Potential Incorrect Peel-Away Sheath Size

    Arrow International is recalling specific lots of ARROW PICC powered by ARROW VPS Stylet kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0188-2018·2017-12-06

    Medtronic Recalls Everflex Self-Expanding Peripheral Stents Due to Labeling Error

    Medtronic is recalling 21 units of Everflex Self-Expanding Peripheral Stents because the stent length on the label may not match the actual stent length.

    Product
    Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0160-2018·2017-11-29

    FDA Recalls Zimmer Biomet ROSA Surgical Devices Due to Sensor Failure

    The FDA is recalling 31 Zimmer Biomet ROSA Surgical Devices because a force feedback sensor may fail, causing the operating arm to continue moving instead of stopping.

    Product
    ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0141-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 537 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0167-2018·2017-11-29

    Zimmer Biomet ROSA Brain 3.0.0 Software Recall for Communication Errors

    Zimmer Biomet is recalling 18 units of ROSA Brain 3.0.0 software due to communication errors between software components and the controller.

    Product
    ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0140-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 547 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0132-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 665 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0135-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech, Inc. is recalling 733 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0137-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 720 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states