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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30376–30400 of 40449

  • HighFDA (Devices)·Z-1519-2016·2016-04-27

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bugs

    Siemens is recalling 1,096 SOMATOM Definition AS CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling specific TC-PLUS knee prostheses because a dimensional deviation may prevent surgeons from seating the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1504-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling the AutoSPECT Pro software application because it may produce erroneous results when processing cardiac SPECT data acquired at detector angles other than 90 or 180 degrees.

    Product
    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1539-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components

    Smith & Nephew is recalling three TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1502-2016·2016-04-27

    Spacelabs Xhibit Telemetry Receiver Recall for Signal Loss

    Spacelabs Healthcare is recalling Xhibit Telemetry Receivers due to frequent signal loss that may cause offline errors on central monitors.

    Product
    The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1548-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Components

    Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper assembly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1514-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Lambswool units because the plastic stabilizer strap may fracture. The recall covers 435 units distributed in the US and Hong Kong.

    Product
    Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling two units of the TC-PLUS Primary Fixed Tibial Component due to a dimensional deviation that may prevent the polyethylene insert from seating properly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1499-2016·2016-04-27

    Leica Surgical Microscopes Recalled for Potential Overheating and Smoke

    Leica Microsystems is recalling 381 M525 and M720 surgical microscopes because an electronic component may overheat, causing smoke and smell.

    Product
    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2016·2016-04-27

    Coloplast Recalls Pediatric Catheters Due to Missing Eyelets

    Coloplast is voluntarily recalling a single lot of Self-Cath Pediatric Catheters because some units have missing eyelets, which can cause catheter malfunction.

    Product
    Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling four units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1516-2016·2016-04-27

    Stryker GDC 360 Detachable Coils Recalled for Incorrect DFU Packaging

    Stryker Neurovascular is recalling GDC 360 Detachable Coils because an incorrect Device Form Unique (DFU) was packaged with two lots.

    Product
    GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients general medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2016·2016-04-27

    Medtronic Recalls CareLink iPro2 Reports Due to Time Zone Error

    Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because they used the wrong time zone, causing inaccurate timestamps for continuous glucose data.

    Product
    CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1524-2016·2016-04-27

    Synthes Recalls Cervical Spine Screws Due to Lot Swapping Error

    Synthes (USA) Products LLC is voluntarily recalling specific lots of cervical spine screws because two different screw types were swapped during manufacturing.

    Product
    Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1498-2016·2016-04-27

    Optovue iVue OCT Systems Recalled for Software Display Anomaly

    Optovue is recalling iVue and iVue 500 OCT systems due to a software anomaly that may display duplicate eye images instead of distinct right and left views.

    Product
    iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and…
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1523-2016·2016-04-27

    Biocare Medical Recalls Mislabeled Mach 4 Mouse Probe Vials

    Biocare Medical is recalling a single lot of Mach 4 Mouse Probe vials that may be mislabeled as HRP-Polymer.

    Product
    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1517-2016·2016-04-27

    Stryker GDC 360 Detachable Coils Recalled for Incorrect Device Formulation

    Stryker Neurovascular is recalling 316 GDC 360 Detachable Coils because an incorrect Device Formulation Unit (DFU) was packaged with the product.

    Product
    GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2016·2016-04-27

    Abbott Recalls CELL-DYN Emerald Cleaner Due to Analyzer Quality Control Issues

    Abbott Laboratories is recalling CELL-DYN Emerald Cleaner because it may cause the hematology analyzer to generate out-of-range quality control results for RBC and PLT.

    Product
    CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1503-2016·2016-04-27

    Ad-Tech Recalls Sterile Electrode Cables Due to Package Failures

    Ad-Tech is recalling 197 unopened sterile electrode connection cables because package failures compromised the sterile barriers.

    Product
    Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal…
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1509-2016·2016-04-27

    OraSure Recalls OraQuick HCV Visual Reference Panel Due to Incorrect Insert

    OraSure Technologies is recalling 244 OraQuick HCV Visual Reference Panel kits because the package insert may be incorrect, potentially containing instructions for a different test.

    Product
    OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2016·2016-04-20

    Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues

    Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.

    Product
    Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1335-2016·2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 18,004 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1339-2016·2016-04-20

    Dexcom G5 Mobile Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 41,925 G5 Mobile Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2016·2016-04-20

    Customed Laparoscopy-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state