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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18226–18250 of 27647

  • HighFDA (Devices)·Z-1683-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.

    Product
    IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    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. 610-527R 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-1617-2018·2018-05-16

    Boston Scientific Recalls Capio SLIM Box 5 Sutures Due to Breakage Risk

    Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.

    Product
    Capio SLIM Box 5, Model #M0068318261; 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-1652-2018·2018-05-16

    Siemens Dimension Glucose Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1697-2018·2018-05-16

    Straumann Emdogain Recalled for Unverified Raw Material Shelf Life Change

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

    Product
    Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1633-2018·2018-05-16

    Vygon Recalls PICC Insertion Kits Due to Sterility Risk

    Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.

    Product
    PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1777-2018·2018-05-16

    Parker Laboratories Recalls Sterile Ultrasound Gel for Potential Seal Leaks

    Parker Laboratories, Inc. is recalling Sterile Aquasonic 100 Ultrasound Transmission Gel because the packet seals may leak.

    Product
    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1670-2018·2018-05-16

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.

    Product
    Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1603-2018·2018-05-09

    Philips MultiDim Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 184 MultiDim Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1605-2018·2018-05-09

    Philips MultiDiagnost Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 37 MultiDiagnost Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2018·2018-05-09

    PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors

    PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.

    Product
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1607-2018·2018-05-09

    Philips MD-Eleva Medical Imaging System Recalled for Tilt Actuator Failure

    Philips is recalling 199 MD-Eleva imaging systems because a tilt actuator may break, causing the table to rotate uncontrollably at high speed.

    Product
    Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1606-2018·2018-05-09

    Philips MD-Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 206 MD-Eleva imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1538-2018·2018-05-09

    Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors

    Zimmer Biomet is recalling 18 modular hip head components because two lots of different sizes were potentially commingled. This may lead to the use of an incorrect sized head.

    Product
    Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1609-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1585-2018·2018-05-09

    Hitachi MHI-TM2000 Linear Accelerator Recalled for Software Anomaly

    Hitachi is recalling one MHI-TM2000 Linear Accelerator System in New York due to a software anomaly that may prevent patient positioning correction, potentially irradiating the wrong body part.

    Product
    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1608-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Recalled Due to Uncontrolled Table Rotation Hazard

    Philips Medical Systems is recalling 184 MultiDiagnostic-Eleva systems because a broken actuator fixation can cause the table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1604-2018·2018-05-09

    Philips URODiagnost Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips Medical Systems is recalling 20 URODiagnost imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1601-2018·2018-05-09

    Southwest Technologies Recalls Hypothermia Mitts, Slippers, and Caps for Misbranding

    Southwest Technologies Inc. is recalling hypothermia mitts, slippers, and caps because they are misbranded for chemotherapy use and linked to two frostbite events.

    Product
    HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1602-2018·2018-05-09

    Southwest Technologies Recalls Hypothermia Slippers Due to Misbranding and Frostbite Reports

    Southwest Technologies is recalling hypothermia slippers because they are misbranded for chemotherapy use and two frostbite events were reported.

    Product
    HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1451-2018·2018-05-09

    Siemens SOMATOM Spirit CT Scanner Recalled for Incorrect Dose Calculations

    Siemens Medical Solutions is recalling SOMATOM Spirit CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation exposure.

    Product
    SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1592-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Exhaust Lines Due to Sterility Concerns

    Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2018·2018-05-09

    Siemens SOMATOM Perspective CT Scanner Recalled for Dose Calculation Error

    Siemens Medical Solutions is recalling 1,301 SOMATOM Perspective CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.

    Product
    SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1546-2018·2018-05-09

    Medi-Vac Suction Canister Liners Recalled for Missing Valve

    Cardinal Health is recalling 3,600 Medi-Vac Flex Advantage Suction Canister Liners distributed in Massachusetts because they may be missing a one-way valve.

    Product
    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up…
    Category
    Medical Device
    Distribution
    1 state