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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

12026–12050 of 27470

  • SevereFDA (Devices)·Z-1240-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2021·2021-03-17

    Draeger VentStar Watertrap Breathing Circuits Recalled for Detachment Risk

    Draeger Medical is recalling 150 units of VentStar Watertrap (N) 180 breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2021·2021-03-17

    Canon Medical System INFX-8000C C-Arm Recall for X-Ray Field Shift

    Canon Medical System is recalling 272 INFX-8000C C-arm systems nationwide because the x-ray irradiation field may shift relative to the displayed image at certain angles.

    Product
    System INFX-8000C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2021·2021-03-17

    Dräger ID Circuit Basic Breathing Circuits Recalled for Detachment Risk

    Dräger Medical is recalling ID Circuit Basic (N) 180 breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2021·2021-03-17

    Sunstar G.U.M. Hydral Dry Mouth Spray Recalled for Bacterial Contamination

    Sunstar Americas is recalling 56,960 bottles of G.U.M. Hydral Dry Mouth Relief Oral Spray due to potential Burkholderia cepacia contamination.

    Product
    SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2021·2021-03-17

    Insulet Recalls Omnipod DASH User Guides Due to Decimal Error

    Insulet Corporation is recalling 21,723 Omnipod DASH User Guides distributed outside the US due to a misprint regarding decimal separators that could lead to incorrect bolus delivery.

    Product
    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1186-2021·2021-03-17

    Stryker Recalls Triathlon Knee Baseplates Due to Manufacturing Defect

    Stryker is recalling 11 Triathlon Tritanium Tibial Baseplates because a manufacturing defect may prevent the knee insert from locking securely.

    Product
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1181-2021·2021-03-17

    Getinge Flow i Anesthesia Systems Recalled for Absorber Docking Failures

    Getinge Group Logistics America is recalling 144 Flow i Anesthesia Systems due to complaints of incorrect FiCO2 readings and System Check Out failures when docking the absorber.

    Product
    Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2021·2021-03-17

    Thermo Fisher Recalls Cascadion Clinical Analyzer Due to Software Defect

    Thermo Fisher Scientific is recalling 19 Cascadion Clinical Analyzers because a software defect may cause false Vitamin D deficiency results.

    Product
    Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1178-2021·2021-03-17

    Dräger VentStar Basic Breathing Circuits Recalled for Detachment Risk

    Draeger Medical is recalling 1,525 VentStar Basic breathing circuits because a Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1156-2021·2021-03-10

    Hamilton Heater Shaker Recalled Due to Fire Risk from Flammable Liquids

    Hamilton Co is recalling 4,729 Heater Shaker units because flammable liquids entering the device can cause a fire.

    Product
    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1159-2021·2021-03-10

    ReNovo Recalls Reprocessed Medical Devices Shipped as Sterile

    ReNovo, Inc. is recalling 81 units of reprocessed medical devices that were shipped to customers labeled as sterile but were non-sterile.

    Product
    Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2021·2021-03-10

    BioFire Film Array BCID Panels Recalled for False Positive Risk

    BioFire Diagnostics is recalling Film Array BCID Panels due to an increased risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC vials.

    Product
    Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2021·2021-03-10

    United Imaging X-ray System Recalled for Uncommanded Motion Hazard

    Shanghai United Imaging Healthcare is recalling six X-ray systems because the tube head may move unexpectedly, posing a collision risk to patients.

    Product
    Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2021·2021-03-10

    BioFire BCID2 Panel Recalled for False Positive Pseudomonas Results

    BioFire Diagnostics is recalling BCID2 Panels due to a risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC blood culture vials.

    Product
    BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2021·2021-03-10

    Baxter Recalls PrisMax Hemodialysis Tubing Due to Performance Variability

    Baxter Healthcare is recalling PrisMax System Version II hemodialysis tubing due to performance variability that may cause alarms and therapy interruptions.

    Product
    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1161-2021·2021-03-10

    ACIST Kodama Intravascular Ultrasound Catheter Recalled for Damaged O-Ring

    Acist Medical Systems is recalling Kodama Intravascular Ultrasound Catheters because damaged o-ring fragments could be flushed out of the device.

    Product
    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2021·2021-03-10

    Siemens Sensis Vibe Systems Recalled for Potential System Freezes

    Siemens is recalling 37 Sensis Vibe systems in the US because they may sporadically freeze during operation or idle, preventing user interaction.

    Product
    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0267-2021·2021-03-03

    CareFusion Recalls ChloraPrep Antiseptic Applicators for Potential Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches in hot, humid climates.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1138-2021·2021-03-03

    DeRoyal Recalls Non-Sterile Sternum Saw Blades in Surgical Packs

    DeRoyal Industries is recalling 309 CV Basin Set Packs because the included sternum saw blades are not sterile.

    Product
    CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1136-2021·2021-03-03

    Ortho-Clinical Recalls Deformed VITROS Chemistry VersaTips

    Ortho-Clinical Diagnostics is recalling deformed VITROS Chemistry VersaTips that may cause assay results to be biased by up to +/-16%.

    Product
    VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips…
    Category
    Medical Device
    Distribution
    Distributed nationwide