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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27426–27450 of 40357

  • HighFDA (Devices)·Z-1473-2017·2017-03-22

    Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage

    Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use, posing a risk of injury to patients or providers.

    Product
    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1464-2017·2017-03-22

    CareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports

    CareFusion is recalling 1,200 MaxGuard Extension Sets because of reports of separation and leakage between the Y-connector and tubing.

    Product
    MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1398-2017·2017-03-22

    Toshiba Ultimax X-ray generator recalled for premature exposure termination

    Toshiba American Medical Systems is recalling 254 Ultimax DREX-ULT80 X-ray generators because the system may terminate exposure prematurely during an examination.

    Product
    Toshiba Ultimax DREX-ULT80 X-ray generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2017·2017-03-22

    Merge Healthcare iConnect Enterprise Archive Software Recall for Routing Errors

    Merge Healthcare is recalling iConnect Enterprise Archive software versions 5.30.0 through 9.4.3 and V11.0 because routing exceptions may delay diagnosis or treatment.

    Product
    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2017·2017-03-22

    CareFusion Recalls MaxGuard Extension Sets Due to Filter Leaks

    CareFusion is recalling 12,850 MaxGuard Extension Sets because the 0.2 micron filter may leak. These medical devices are used to administer fluids to patients.

    Product
    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2017·2017-03-22

    Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage

    Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use. The recall covers 1,096 units distributed in the US and two countries.

    Product
    SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1481-2017·2017-03-22

    Philips BrightView X Nuclear Imaging System Recalled for Four Software and Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView X nuclear imaging systems worldwide due to four issues: motion controller failures, door interlock problems, detector contact risks, and software freezes.

    Product
    882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2017·2017-03-22

    C2 CryoBalloon Controller Cap Recall Due to Cracking Risk

    C2 Therapeutics is recalling 755 C2 CryoBalloon Controller Caps because they may crack when tightened, potentially compromising the device's integrity.

    Product
    C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling Reddick Cholangiogram Catheters because the latex symbol was not printed on the packaging, posing a risk to latex-allergic patients.

    Product
    LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling 2,065 units of Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2017·2017-03-22

    Kiscomedica Recalls L-Varlock Cage/Trial Implant Holder Due to Breakage

    Kiscomedica S.A. is recalling 13 units of the L-Varlock Cage/Trial Implant Holder because the tip holder broke during use.

    Product
    L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2017·2017-03-22

    Acumed Orthopedic Guide Wires Recalled Due to Packaging Errors

    Acumed LLC is recalling specific lots of .045 and .054 orthopedic guide wires because they were mis-packaged with incorrect size labels.

    Product
    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1397-2017·2017-03-22

    Toshiba Kalare X-ray Generator Recalled for Premature Exposure Termination

    Toshiba American Medical Systems Inc is recalling 254 Kalare DREX-KL80 X-ray generators because the system may terminate exposure prematurely during an examination.

    Product
    Toshiba Kalare DREX-KL80 X-ray generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1480-2017·2017-03-22

    Philips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues

    Philips Medical Systems is recalling 1,218 BrightView nuclear imaging systems worldwide due to four issues, including motion controller failures and software freezes.

    Product
    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1465-2017·2017-03-22

    Smiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes

    Smiths Medical is recalling 142 Bivona TTS Pediatric Tracheostomy Tubes because they were incorrectly labeled for neonatal use instead of pediatric use.

    Product
    Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1444-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 608 Reddick Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1466-2017·2017-03-22

    Siemens Artis Q and Q.Zen Fluoroscopic X-Ray System Recall

    Siemens is recalling Artis Q and Q.Zen fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Artis Q and Q.Zen fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1451-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 247 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2017·2017-03-22

    GE OEC FlexiView 8800 Imaging System Recalled for Power Cord Failures

    GE is recalling OEC FlexiView 8800 systems where specific power cords were replaced in 2016 due to intermittent failures causing loss of imaging functionality.

    Product
    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1458-2017·2017-03-22

    Terumo Level Sensor II Pads Recalled for Non-Compliant Expiration Date Labeling

    Terumo Cardiovascular Systems Corporation is voluntarily recalling Level Sensor II Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1478-2017·2017-03-22

    Inion GRT Tack Recall Due to Defective Aluminum Pouch Seal

    Inion Ltd. is recalling 36 sterile Inion GRT Tack kits distributed in Florida and North Carolina because the aluminum pouch seal was found to be slightly open.

    Product
    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1459-2017·2017-03-22

    Terumo Level Sensor Gel Pads Recalled for Non-Compliant Labeling

    Terumo is voluntarily recalling Level Sensor II Gel Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1457-2017·2017-03-22

    Merge Hemo software recalled due to study tab locking issue

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the system may incorrectly lock study tabs, potentially preventing access to data.

    Product
    Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
    Category
    Medical Device
    Distribution
    Distributed nationwide