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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

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27951–27975 of 40357

  • ModerateFDA (Devices)·Z-0997-2017·2017-01-18

    Siemens Biograph mCT X-3R Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 18 Biograph mCT X-3R scanners because laser cover windows may fall off.

    Product
    Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1004-2017·2017-01-18

    Philips Brilliance iCT CT System Recalled for Undocumented Installation

    Philips Medical Systems is recalling one Brilliance iCT system because the installation of four M12 bolts was not correctly documented.

    Product
    Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0926-2017·2017-01-11

    Nurse Assist Recalls Normal Saline Flush Syringes Due to B. cepacia Contamination

    Nurse Assist, Inc. is recalling Normal Saline Flush syringes due to potential contamination with B. cepacia. The affected products were distributed in the US, US Virgin Islands, and Canada.

    Product
    Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2017·2017-01-11

    Pride Mobility Recalls TRU-Balance 3 Power Positioning Systems

    Pride Mobility Products Corp is recalling 12,343 TRU-Balance 3 Power Positioning Systems because the back and tilt base can separate when tilted beyond the specified angle.

    Product
    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2017·2017-01-11

    Smith & Nephew Recalls Modular Hip Prosthesis Necks Due to Adverse Events

    Smith & Nephew is recalling 13,671 modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend.

    Product
    Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2017·2017-01-11

    Smith & Nephew Recalls Modular SMF Hip Prostheses Due to Adverse Events

    Smith & Nephew is recalling Modular SMF and Modular REDAPT Hip Systems due to a higher-than-anticipated trend in complaints and adverse events.

    Product
    Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2017·2017-01-11

    Smith & Nephew Recalls Modular REDAPT Hip Systems Due to Adverse Events

    Smith & Nephew is recalling 6,266 units of Modular REDAPT and Modular SMF Hip Systems worldwide due to a higher than anticipated complaint and adverse event trend.

    Product
    Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2017·2017-01-11

    Interventional Spine Recalls G3 Opticage Expandable Interbody Fusion Devices

    Interventional Spine Inc is recalling 239 G3 Opticage Expandable Interbody Fusion Devices because the proximal end may separate during implantation, preventing the device from expanding.

    Product
    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2017·2017-01-11

    Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association

    Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0947-2017·2017-01-11

    Aesculap Recalls Gomco Circumcision Clamps Due to Excessive Bleeding Reports

    Aesculap Implant Systems LLC is recalling 437 units of Gomco Circumcision Clamps nationwide after receiving complaints of excessive bleeding following use.

    Product
    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2017·2017-01-11

    Tepha GalaSHAPE 3D Medical Device Recalled for Endotoxin Specification Exceedance

    Tepha Incorporated is recalling 29 units of GalaSHAPE 3D medical devices because endotoxin levels slightly exceeded specifications.

    Product
    GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2017·2017-01-11

    Merit PreludeEASE Hydrophilic Sheath Introducer Dilator Recall

    Merit Medical Systems is recalling 335 PreludeEASE Hydrophilic Sheath Introducer Dilators because the tips are undersized and cannot pass a 0.021-inch guide wire.

    Product
    PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0943-2017·2017-01-11

    MicroPort Orthopedics Recalls Profemur R Rasp Handles Due to Machining Issues

    MicroPort Orthopedics is recalling 20 units of Profemur R Rasp Handles because machining issues may prevent them from properly mating with broaches.

    Product
    PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0940-2017·2017-01-11

    Infraredx Recalls TVC Imaging System Due to Image Appearance Issues

    Infraredx, Inc. is recalling seven TVC Imaging System units because near-infrared images sometimes displayed lipid core plaques with an unusual horizontal orientation.

    Product
    TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0919-2017·2017-01-04

    Siemens Recalls SOMATOM Scope CT Systems for Power Cutout Risk

    Siemens is recalling 13 SOMATOM Scope CT systems to replace a component that could cause a power cutout during use.

    Product
    SOMATOM Scope, Computed tomography x-ray system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0928-2017·2017-01-04

    Allen Medical Systems Recalls Arthex S3 Arm Sleeve Connectors

    Allen Medical Systems is recalling 420 Arthex S3 Arm Sleeve Connectors because they may separate unexpectedly during use, potentially causing moderate injury to patients.

    Product
    Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0916-2017·2017-01-04

    GE Healthcare Recalls X-Ray Systems Due to CRT Monitor Fall Risk

    GE Healthcare is recalling specific X-ray systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.

    Product
    SFX
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0906-2017·2017-01-04

    GE Healthcare Recalls CRT Monitors Due to Potential Fall Hazard

    GE Healthcare is recalling specific CRT monitors due to the potential for the units to fall. The recall affects multiple system models including ADVANTX and Prestige.

    Product
    ADVANTX LCLP+
    Category
    Medical Device
    Distribution
    41 states