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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40426–40450 of 40480

  • 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
  • ModerateFDA (Devices)·Z-1824-2012·2012-06-27

    App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues

    App Pharmaceuticals is recalling Heparin Lock Flush Solution vials due to incomplete documentation of test results. The recall covers 133,150 vials distributed nationwide and in Puerto Rico.

    Product
    HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1822-2012·2012-06-27

    Ultradent Recalls Peak SE Primer Kits Due to Mislabeled Syringes

    Ultradent is recalling specific Peak SE Primer Kits because a syringe was mislabeled as Peak LC Bond Resin, posing a risk to dental bonding procedures.

    Product
    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1813-2012·2012-06-27

    Tripath PrepStain Installation Kit Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.

    Product
    PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1812-2012·2012-06-27

    Tripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.

    Product
    PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1850-2012·2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling Profile Single-Use Pediatric Snares due to difficulty extending the snare loop from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , 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
  • ModerateFDA (Devices)·Z-1820-2012·2012-06-27

    NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

    Non-Invasive Monitoring Systems, Inc. is voluntarily recalling 91 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.

    Product
    USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2012·2012-06-27

    Philips MultiDiagnost Eleva X-Ray System Cable Damage Recall

    Philips Healthcare is recalling 433 MultiDiagnost Eleva X-ray systems worldwide due to potential damage to system cables from repeated movement.

    Product
    Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1831-2012·2012-06-27

    Spacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software

    Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.

    Product
    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1811-2012·2012-06-27

    Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect

    Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.

    Product
    PrepStain Syringing Pipettes 240 (Catalog #490517)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1853-2012·2012-06-27

    Accumetrics Recalls VerifyNow P2Y12 Assay for Field Correction

    Accumetrics is recalling the VerifyNow P2Y12 Assay to implement a field correction that eliminates the reporting of BASE and % Inhibition results.

    Product
    VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1819-2012·2012-06-27

    NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

    Non-Invasive Monitoring Systems is voluntarily recalling 3,665 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.

    Product
    US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure…
    Category
    Medical Device
    Distribution
    Distributed nationwide