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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27651–27675 of 27681

  • HighFDA (Devices)·Z-1849-2012·2012-06-27

    Medtronic 0-arm Imaging System Recalled for Navigational Accuracy Issues

    Medtronic is recalling three 0-arm Imaging Systems because software version 3.1.1 does not meet navigational accuracy standards.

    Product
    Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that can be dislodged.

    Product
    SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2012·2012-06-27

    Genzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect

    Genzyme is recalling Seprafilm Procedure Packs because a packaging defect may compromise the product's sterility. The recall affects units distributed in the US and South Korea.

    Product
    seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2012·2012-06-27

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that could dislodge during use.

    Product
    SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.

    Product
    24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2012·2012-06-27

    FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of the Covidien ROTICULATOR 30-4.8 Single Use Stapler because the sterility barrier may be compromised.

    Product
    Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2012·2012-06-27

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connectors can be dislodged during use.

    Product
    SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2012·2012-06-27

    Natus Olympic Cool-Cap System Recalled Due to Power Supply Failure

    Natus Medical is recalling 181 Olympic Cool-Cap Systems because the power supply may fail without warning, interrupting cooling treatment for infants.

    Product
    Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1836-2012·2012-06-27

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that can be dislodged.

    Product
    SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.

    Product
    CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2012·2012-06-27

    Genzyme Recalls Seprafilm Adhesion Barrier Due to Packaging Sterility Risk

    Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier because a packaging defect may compromise product sterility.

    Product
    seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2012·2012-06-27

    Philips Easy Diagnost Fluoroscopic System Recalled for Measurement Errors

    Philips Healthcare Inc. is recalling six Easy Diagnost stationary fluoroscopic systems because misaligned lead rulers can cause incorrect distance measurements, potentially affecting surgical interventions.

    Product
    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1832-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulas because a foreign substance found on connectors can be dislodged during use.

    Product
    SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2012·2012-06-27

    Biomet 3i Recalls Dental Implants Due to Missing Internal Thread

    Biomet 3i is recalling specific Osseotite dental implants because they may lack an internal thread. The recall affects 219 units distributed in the US and internationally.

    Product
    Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2012·2012-06-27

    Stryker Accolade Offset Rasp Handle Recalled for Potential Fracture

    Stryker Howmedica Osteonics is recalling 41 Accolade Offset Rasp Handles due to a potential risk of fracturing during use in total hip arthroplasty.

    Product
    Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2012·2012-06-27

    Boston Scientific Recalls Pediatric Polypectomy Snares Due to Extension Difficulty

    Boston Scientific is recalling 1,340 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.

    Product
    SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2012·2012-06-27

    Philips Digital Diagnost Software Recall for Image Marker Error

    Philips Healthcare Inc. is recalling Digital Diagnost Software releases 2.0.2 and 2.0.2SP1 because a mirrored image marker can be mistaken for a right-side patient indicator.

    Product
    Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1834-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that could be dislodged.

    Product
    SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2012·2012-06-27

    FDA Recalls Covidien Roticalutor Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of the Covidien Roticalutor 30-V3 Single Use Stapler because the sterility barrier may be compromised.

    Product
    Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.

    Product
    CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2012·2012-06-27

    American Optisurgical Recalls TX1 Tissue Removal System Consoles

    American Optisurgical Inc is recalling five TX1 Tissue Removal System Consoles due to an incorrect pressure relief valve and inaccurate technical specifications.

    Product
    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1490-2012·2012-06-20

    Baxter Sigma Spectrum Infusion Pump Recall for Bearing Failure Risk

    Baxter Healthcare is recalling 63,225 Sigma Spectrum Infusion Pumps because bearing lubricant loss can cause flow failures and potential over-infusion.

    Product
    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2012·2012-06-20

    Stryker T4-Hytrel Zipper Toga Recall Due to Missing Tape

    Stryker is recalling T4-Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.

    Product
    T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2012·2012-06-20

    Stryker T5 Hytrel Zipper Toga Recalled for Missing Protective Tape

    Stryker is recalling T5 Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.

    Product
    T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide