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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28076–28100 of 40233

  • ModerateFDA (Devices)·Z-0756-2017·2016-12-21

    Recall of Sterile Specimen Containers Due to Packaging Defect

    Covidien LLC is recalling 5,187,100 sterile specimen containers because a packaging defect compromised the sterility of the outer surface.

    Product
    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2017·2016-12-21

    C.R. Bard Recalls Piston Syringes Due to Package Defect Risk

    C.R. Bard is recalling specific lots of 60cc Piston Syringes because a package slit defect may compromise product sterility.

    Product
    BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0742-2017·2016-12-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve performance.

    Product
    SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0741-2017·2016-12-21

    Cypress Medical Recalls McKesson Vinyl Exam Gloves for Leak Test Failure

    Cypress Medical Products is recalling McKesson Powder Free Vinyl Exam Gloves because a container failed the FDA leak test. The recall is limited to one distribution center in Auburn, Washington.

    Product
    McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0744-2017·2016-12-21

    Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2017·2016-12-21

    Ulthera Recalls Cellfina Prep Packs Due to Non-Sterile Vacuum Tube

    Ulthera Inc is recalling Cellfina Prep Packs because they contain a non-sterile vacuum tube, while the instructions describe using a sterile tube.

    Product
    Cellfina Prep Pack, Part No. CP1
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0738-2017·2016-12-21

    C.R. Bard Recalls BARDIA 60cc Piston Irrigation Syringes Due to Package Defect

    C.R. Bard is recalling BARDIA 60cc Piston Irrigation Syringes because a slit defect in the packaging may compromise product sterility.

    Product
    BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0740-2017·2016-12-21

    BD Recalls Spinal Anesthesia Trays Due to Incorrect Labeling

    Becton Dickinson is recalling 4,500 BD Spinal Anesthesia Trays because a small number were incorrectly labeled as Epidural Trays.

    Product
    BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2017·2016-12-21

    Natus neoBLUE Phototherapy Systems Recalled for Fiberoptic Pad Failure

    Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to early failure of fiberoptic pads, which can cause discoloration and melting at the connector.

    Product
    Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0757-2017·2016-12-21

    Pentax Ultrasound Video Bronchoscope Recalled for Incorrect Instructions

    Pentax of America Inc. is recalling 113 Ultrasound Video Bronchoscopes because they shipped with outdated instructions for use.

    Product
    Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2017·2016-12-21

    Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

    Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

    Product
    LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0659-2017·2016-12-14

    SynCardia Freedom Driver System Recalled for Potential Silent Failure

    SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.

    Product
    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0699-2017·2016-12-14

    Tornier Recalls Aequalis Fx2 Shoulder Implant Parts Due to Dislocation Reports

    Tornier is recalling Aequalis Fx2 implant parts and instrument trays due to reports of poly insert and stem dislocations.

    Product
    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0647-2017·2016-12-14

    Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

    Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

    Product
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0702-2017·2016-12-14

    Thayer MANOS EX Surgical Device Recalled for Missing Safety Warning

    Thayer Intellectual Property, Inc. is recalling 339 MANOS EX surgical devices because customers were not notified of a critical safety warning regarding device bending and breakage.

    Product
    MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0727-2017·2016-12-14

    AMD-Ritmed Transparent Dressing Recalled for Sterility Failure

    AMD-Ritmed is recalling Lot 68408 of transparent dressings because FDA testing found the sterile products were contaminated.

    Product
    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0701-2017·2016-12-14

    3M Recalls Universal Electrosurgical Pads Due to Unintended Material Defect

    3M is recalling Universal Electrosurgical Pads because an unintended process liner may impede the safe return of electrosurgical current, increasing the risk of patient burns.

    Product
    3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2017·2016-12-14

    Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results

    Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0707-2017·2016-12-14

    Merge Healthcare Recalls eFilm Workstation Software Due to Measurement Errors

    Merge Healthcare is recalling eFilm Workstation software versions 2.1 through 4.1 because RF projection images may display incorrect measurements without a calibration indicator.

    Product
    Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2017·2016-12-14

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software versions 4.0, 4.5, 4.7, and 5.0 due to potential inaccuracies in proton dose calculations for specific treatment plans.

    Product
    RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2017·2016-12-14

    Olympus Vanta Analytical X-Ray System Recalled for Unintentional Emission Risk

    Olympus is recalling 41 Vanta Analytical X-Ray Systems due to a risk of unintentional x-ray emission if users attempt to terminate the sequence early.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0693-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.

    Product
    Brilliance 64 728231 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 analysis and display equipment, patient and…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0697-2017·2016-12-14

    Philips Ingenuity CT Systems Recalled for Software Timer Error

    Philips Medical Systems is recalling 371 Ingenuity CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity CT 728326 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 analysis and display equipment, patient and…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0703-2017·2016-12-14

    DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect

    DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.

    Product
    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
    Category
    Medical Device
    Distribution
    1 state