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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18151–18175 of 27647

  • HighFDA (Devices)·Z-1621-2018·2018-05-16

    Boston Scientific Recalls Capio RP Sutures Due to Breakage Risk

    Boston Scientific is recalling 2,567 units of Capio RP sutures because they may break or detach during surgery.

    Product
    Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1619-2018·2018-05-16

    Boston Scientific Recalls Capio Open Access Box 4 Sutures

    Boston Scientific is recalling 21,051 units of Capio Open Access Box 4 sutures due to a potential for the sutures to break or detach during use.

    Product
    Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1636-2018·2018-05-16

    Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise

    Vygon U.S.A. is recalling Maximum Barrier Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

    Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screws because they were overexposed to ethylene oxide sterilization, which may compromise the sterile barrier.

    Product
    Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2018·2018-05-16

    Microline Surgical Recalls ReNew Dolphin Nose Disposable Dissector Tips

    Microline Surgical is recalling specific lots of ReNew Dolphin Nose Disposable Dissector Tips due to a potentially compromised sterile barrier.

    Product
    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1781-2018·2018-05-16

    Ninepoint Medical Recalls NvisionVLE Low-Profile Optical Probes

    Ninepoint Medical is recalling 152 NvisionVLE Low-Profile Optical Probes because the distal tips may detach from the probe shaft during use.

    Product
    NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2018·2018-05-16

    Siemens Tacrolimus Assay Recalled for Interference with Sulfasalazine and Sulfapyridine

    Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1667-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Incomplete Testing Documentation

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because final release testing was improperly documented, omitting critical safety checks.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2018·2018-05-16

    Siemens Syngo.plaza Software Recalled to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2018·2018-05-16

    Boston Scientific Recalls Uphold LITE Pelvic Organ Prolapse Mesh Devices

    Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices due to a potential for the Capio sutures to break or detach.

    Product
    Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1629-2018·2018-05-16

    Abbott ARCHITECT DHEA-S Reagent Recalled for False Infant Results

    Abbott is recalling ARCHITECT DHEA-S Reagent because it may produce falsely elevated results when used on samples from infants up to 60 days old.

    Product
    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1695-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Change

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf life change was made without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling 5 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1648-2018·2018-05-16

    Siemens ADVIA Salicylate Reagent Recalled for Potential Test Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate results.

    Product
    ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1618-2018·2018-05-16

    Boston Scientific Recalls Capio CL Sutures Due to Breakage Risk

    Boston Scientific is recalling 1,258 Capio CL sutures because they may break or detach during transvaginal procedures.

    Product
    Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1776-2018·2018-05-16

    Transonic ADT1018 Hemodialysis Tubing Recalled Due to Sterility Concerns

    Transonic Systems Inc. is recalling ADT1018 Flow QC Clear Advantage Tubing because the sterility of the device cannot be assured, posing a potential risk of infection.

    Product
    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliance

    TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1645-2018·2018-05-16

    Deerfield Imaging Recalls IMRIS Intraoperative MRI Systems Due to Malfunction

    Deerfield Imaging is recalling 10 IMRIS intraoperative MRI systems because magnetic fields cause the IFOSS collision detector control panel to malfunction.

    Product
    IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2018·2018-05-16

    Maquet Cardiohelp Gas Bottle Holder Recalled for Potential Clamp Failure

    Maquet Cardiopulmonary Ag is recalling 14 units of the Cardiohelp Gas Bottle Holder HKH 8880 because the clamps may crack or break during strong vibrations.

    Product
    CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1685-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1616-2018·2018-05-16

    Boston Scientific Recalls Capio SLIM Suture Capturing Device Due to Breakage Risk

    Boston Scientific is recalling 21,250 units of the Capio SLIM Suture Capturing Device because the sutures may break or detach during surgery.

    Product
    Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1705-2018·2018-05-16

    Zimmer Biomet Recalls Lactosorb RapidFlap Bone Plates Due to Threading Defect

    Zimmer Biomet is recalling Lactosorb RapidFlap bone plates because excessive chamfering on the threads prevents proper engagement with the post component.

    Product
    Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1626-2018·2018-05-16

    Boston Scientific Recalls Uphold Vaginal Support System Due to Suture Breakage

    Boston Scientific is recalling 1,002 Uphold Vaginal Support Systems because the Capio sutures may break or detach.

    Product
    Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1750-2018·2018-05-16

    Medtronic ZEVO Anterior Cervical Plate System Slot Screw Recall

    Medtronic is recalling 39 ZEVO Anterior Cervical Plate System slot screws because they are 15mm long instead of the specified 17mm.

    Product
    Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
    Category
    Medical Device
    Distribution
    Distributed nationwide