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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26776–26800 of 40233

  • ModerateFDA (Devices)·Z-2054-2017·2017-05-17

    CooperSurgical lnflatoball Pessary Recalled for Incorrect Latex-Free Labeling

    CooperSurgical is recalling lnflatoball Latex Rubber Pessaries because the secondary packaging incorrectly states the product is latex-free, despite being made of 100% latex.

    Product
    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2057-2017·2017-05-17

    Med-Hot Thermal Imaging System Recalled for Lack of FDA Clearance

    Med-Hot Thermal Imaging, Inc. is recalling 12 units of the MTI 2000 Thermal Imaging System because the indications for use are not cleared or approved for the U.S. market.

    Product
    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2071-2017·2017-05-17

    Stryker PROFESS Registration Kit Recalled for Expiration Date Issues

    Stryker is recalling 65 PROFESS Registration Kits shipped near or past their expiration dates. The kits are used for intranasal and sinus surgery.

    Product
    Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2017·2017-05-17

    Almore Microfil Composite Instruments Recalled for Incorrect Sterile Labeling

    Almore International Inc. is recalling Microfil Composite Instruments because packaging labels incorrectly display a sterile symbol, although the devices are not sterile.

    Product
    Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2070-2017·2017-05-17

    Mentor Breast Implant Recall Due to Missing Dome Pack Accessory

    Mentor Texas, LP. is recalling 28 units of Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implants because the Dome Pack accessory is missing.

    Product
    Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1929-2017·2017-05-10

    Olympus Endoeye HD II Video Telescopes Recalled for Overheating Tip

    Olympus is recalling 863 Endoeye HD II video telescopes because a damaged temperature sensor can cause the tip to become abnormally hot.

    Product
    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1874-2017·2017-05-10

    Medtronic Recalls Newport HT70 Ventilators Due to Spontaneous Shutdown Risk

    Medtronic is voluntarily recalling Newport HT70 and HT70 Plus ventilators because they may shut down spontaneously without an alarm during normal operation.

    Product
    Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2034-2017·2017-05-10

    Sysmex XN Series Hematology Analyzers Recalled for Fire Risk

    Sysmex America Inc is recalling XN-10 and XN-11 hematology analyzers due to a risk of fire caused by misaligned internal protective sheets.

    Product
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1899-2017·2017-05-10

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Error

    Roche Diabetes Care is recalling specific versions of the Accu-Chek Connect app because a bug in the Bolus Advisor feature may provide incorrect insulin dosing advice.

    Product
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1924-2017·2017-05-10

    Natus Medical Recalls neoBLUE 2 Phototherapy Lights for Intensity Defect

    Natus Medical is recalling neoBLUE 2 phototherapy lights sold from 2003 to 2008 to prevent the use of replacement boards that allow higher light intensity than originally cleared.

    Product
    Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2017·2017-05-10

    Dale Medical Stabilock Endotracheal Adhesive Base Recalled for Adhesive Failure

    Dale Medical Products is recalling Stabilock Endotracheal Adhesive Bases because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.

    Product
    Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2017·2017-05-10

    Medtronic Recalls MiniMed 620G and 640G Insulin Pumps Due to Software Anomaly

    Medtronic is recalling MiniMed 620G and 640G insulin pumps with software version 2.6 or below because a software anomaly can prevent the internal battery from charging, leading to pump shutdown.

    Product
    MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1903-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Dressing Rect L (P/N 02428) because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2017·2017-05-10

    Merge Healthcare Recalls Schiller CO2 Sensors Due to Alarm Bias

    Merge Healthcare is recalling 23 Schiller CO2 sensors that may display false clogging alarms, potentially adding bias to CO2 measurements and affecting alarm notifications.

    Product
    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1900-2017·2017-05-10

    Bard MR GHIATAS Beaded Breast Localization Wire Recalled for Compatibility Risk

    Bard Peripheral Vascular Inc. is recalling 570 units of MR GHIATAS Beaded Breast Localization Wire because they may be non-MR compatible instead of MR compatible.

    Product
    MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2017·2017-05-10

    BD FlowSmart Set MiniMed Pro-set Recalled for Bent Catheters

    Becton Dickinson is recalling 57,750 units of BD FlowSmart Set MiniMed Pro-set in California due to reports of bent catheters causing high blood glucose.

    Product
    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1921-2017·2017-05-10

    Roho Sensor Ready Cushions Recalled for Improper Setup Risk

    Roho Inc. is recalling 5,646 units of ROHO High and Mid Profile cushions because the Smart Check tool may cause improper inflation, increasing the risk of skin or soft tissue injury.

    Product
    ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2017·2017-05-10

    Dale Medical Stabilock Endotracheal Tube Holder Recall for Adhesive Failure

    Dale Medical Products is recalling Stabilock Endotracheal Tube Holders because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.

    Product
    Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2017·2017-05-10

    Anspach Effort Recalls Bearing Sleeves Due to Missing Service Interval

    The Anspach Effort, Inc. is recalling 182 Bearing Sleeve, 10CM Curved units because the supplied directions for use did not contain a recommended service interval.

    Product
    Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1953-2017·2017-05-10

    Anspach Effort SC2100 Foot Control Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 320 SC2100 Foot Controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Foot Control, SC2100 Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2017·2017-05-10

    Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 297 pneumatic system attachments because the supplied directions for use did not include a recommended service interval.

    Product
    6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2017·2017-05-10

    Anspach Effort Recalls 14cm QD Angle Attachment for Pneumatic Systems

    The Anspach Effort, Inc. is recalling 238 units of the 14cm QD Angle Attachment because the supplied directions for use did not contain a recommended service interval.

    Product
    14cm QD Angle Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life

    Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide