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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21751–21775 of 27699

  • HighFDA (Devices)·Z-1589-2016·2016-05-11

    GE Revolution CT Recalled for Potential X-Ray Tube Loosening

    GE Medical Systems is recalling 26 Revolution CT systems worldwide because a manufacturing error may cause the X-ray tube to loosen, leading to scan errors or image artifacts.

    Product
    GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1596-2016·2016-05-11

    bioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards

    bioMerieux is recalling VITEK 2 Gram Positive Susceptibility Test Cards because they may produce false susceptible results for specific bacteria to Minocycline.

    Product
    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1250-2016·2016-05-04

    Tarry Medical Recalls DandleLION Kisses Due to Microbial Contamination

    Tarry Medical Products is recalling DandleLION Kisses sterile sucrose solution due to microbial contamination. The product is distributed in nine states.

    Product
    DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use Part Number D 12442 C384
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1580-2016·2016-05-04

    Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking

    Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.

    Product
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1583-2016·2016-05-04

    Mako Surgical Recalls RESTORIS PST RIO Offset Shell Impactor

    Mako Surgical Corporation is recalling 96 units of the RESTORIS PST RIO Offset Shell Impactor due to a potential disassociation of the orientation pin.

    Product
    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2016·2016-05-04

    Research Instruments Recalls Integra 3 Micromanipulators Due to Faulty Power Cable

    Research Instruments Ltd is recalling 380 Integra 3 micromanipulators because they were fitted with a potentially faulty power supply cable.

    Product
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 and C400 Clinical Chemistry Analyzers

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers due to malfunctions triggered by specific system alarms.

    Product
    Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2016·2016-05-04

    GE Healthcare Aisys Anesthesia Machines Recalled for Suction Tubing Defect

    GE Medical Systems is recalling Aisys and Aisys CS2 anesthesia machines because kinked vacuum suction tubing may cause inadequate airway clearance and ventilation.

    Product
    GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1559-2016·2016-05-04

    Becton Dickinson Recalls Listeria-Contaminated Trypticase Soy Agar Plates

    Becton Dickinson is recalling Trypticase Soy Agar and MacConkey II Agar plates contaminated with Listeria monocytogenes. The non-sterile media are used for growing and detecting bacteria.

    Product
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 Analyzers Due to Malfunctions

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers because they malfunction when specific alarms appear on the system.

    Product
    ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2016·2016-05-04

    Elekta Radionuclide Radiation Therapy System Recalled for Frame Adapter Latch Defect

    Elekta is recalling 217 Radionuclide Radiation Therapy Systems because frame adapter latches can lock without proper pin insertion, potentially compromising treatment accuracy.

    Product
    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2016·2016-05-04

    3M Steri-Vac Gas Sterilizer Valves Recalled for Labeling Error

    3M is recalling 74 Steri-Vac Gas Sterilizer valves due to a labeling error that could cause incorrect installation and potential valve failure.

    Product
    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1558-2016·2016-05-04

    Siemens SOMATOM Force CT Systems Recalled for Image Artifacts

    Siemens is recalling 37 SOMATOM Force CT systems because a software error in the Neonate Head protocol may cause image artifacts, potentially leading to misdiagnosis.

    Product
    SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2016·2016-05-04

    Hologic Recalls CF InPlex ASR Cards Due to False Positive Results

    Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.

    Product
    CF InPlex ASR Card; Catalog Number: 95-0501.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1578-2016·2016-05-04

    Roche IT3800 Hand-Held Barcode Scanner Recalled for Mis-Identification

    Roche Molecular Systems is recalling 6,939 IT3800 hand-held barcode scanners because they mis-identified sample barcodes when used with the COBAS AmpliPrep instrument.

    Product
    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2016·2016-05-04

    Philips NeuViz 16 CT Scanner Recall for Patient Data Error

    Philips and Neusoft are recalling 37 NeuViz 16 CT scanners due to a software defect that may allow previous patient images to be pasted into the current patient's record.

    Product
    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1585-2016·2016-05-04

    Shimadzu X-Ray Diagnostic Table Recalled for Unintentional Reverse Tilting

    Shimadzu Medical Systems is recalling 185 X-Ray Diagnostic Tables (Model YSF-300) due to reports of unintentional movement to reverse tilting.

    Product
    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2016·2016-05-04

    Intuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk

    Intuitive Surgical is recalling 43 EndoWrist Stapler instruments for the da Vinci Xi system due to a risk of unexpected jaw motion during use.

    Product
    EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1529-2016·2016-04-27

    Mevion S250 Proton Therapy System Recalled for Gantry Motion Hazard

    Mevion Medical Systems is recalling five MEVION S250 proton therapy systems because an aperture may fall out during gantry motion, posing a risk of traumatic injury or death to patients.

    Product
    MEVION S250 for Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1342-2016·2016-04-27

    Boston Scientific Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks

    Boston Scientific is recalling Fetch 2 Aspiration Catheters because the catheter shafts may break, potentially requiring additional procedures to remove the broken piece from patients.

    Product
    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1551-2016·2016-04-27

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

    Smith & Nephew is recalling 6 units of TC-PLUS tibial knee prostheses due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1530-2016·2016-04-27

    Acorn 180 Curved Stairlift Recalled Due to Broken Rivets

    Acorn Stairlifts Inc is recalling 1,290 Acorn 180 Curved Stairlifts in the US because aluminum rivets may break under prolonged use.

    Product
    Acorn 180 Curved Stairlift
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Sorbatex units because the plastic stabilizer strap may partially or completely fracture.

    Product
    Ossur Lil Angel Vest P3 Sorbatex. 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-1545-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Components Due to Dimensional Deviation

    Smith & Nephew is recalling 22 units of TC-Plus tibial knee components distributed in Germany and Switzerland due to a dimensional deviation that may prevent proper seating of the polyethylene insert.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states