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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16101–16125 of 27471

  • HighFDA (Devices)·Z-1187-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Malleable Monopolar Blades

    Gyrus ACMI is recalling 161 Diego Elite Malleable 4mm Standard Monopolar Blades because they may allow unintended RF energy activation when used with Diego Elite consoles.

    Product
    Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 630 Angiographic X-Ray System

    GE Healthcare is recalling one Innova IGS 630 angiographic X-ray system because a specific user action may cause a loss of imaging function.

    Product
    Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2019·2019-04-24

    Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk

    Medrobotics is recalling 24 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.

    Product
    Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2019·2019-04-24

    bioMerieux Recalls Vitek 2 Test Kits Due to False ESBL Results

    bioMerieux is recalling Vitek 2 test kits because they may incorrectly identify Escherichia coli as having an ESBL phenotype.

    Product
    Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1145-2019·2019-04-24

    Roche Bilirubin Total Gen.3 Recalled for Potential Medical Risk

    Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.

    Product
    Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 82 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate Risk

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2019·2019-04-24

    Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk

    Medrobotics is recalling 35 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.

    Product
    Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1146-2019·2019-04-24

    Roche Lactate Gen.2 Recalled Due to Endogenous Interference Claims

    Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.

    Product
    Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2019·2019-04-24

    Bioventus Recalls Bioactive Bone Graft Putty Due to Sterility Risk

    Bioventus is recalling 10,793 units of Bioactive Bone Graft Putty because sterile pouches may puncture during transit, potentially introducing non-sterile devices and causing patient infection.

    Product
    BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1184-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 193 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 630 X-Ray Systems for Imaging Loss

    GE Healthcare is recalling 49 Innova IGS 630 Interventional Fluoroscopic X-Ray Systems due to a potential loss of x-ray imaging function when changing the field of view while releasing the footswitch.

    Product
    Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 13 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with compatible consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 6 X-Ray Systems Due to Imaging Loss

    GE Healthcare is recalling 22 Innova IGS 6 Interventional Fluoroscopic X-Ray Systems because they may lose x-ray imaging function during specific field of view changes.

    Product
    Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2019·2019-04-24

    Pintler Medical Recalls 24 Warming Pads Due to Malfunction

    Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.

    Product
    A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1132-2019·2019-04-24

    Wilson-Cook Recalls Acusnare Polypectomy Snares Due to Loop Retraction Issues

    Wilson-Cook Medical Inc. is recalling 34,456 Acusnare Polypectomy Snares because the snare loop may not completely retract or may misshape.

    Product
    Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2019·2019-04-24

    Olympus Diego Elite Console Recall for Unintended RF Energy Activation

    Gyrus ACMI is recalling Olympus Diego Elite Consoles because they may inadvertently activate the RF energy feature when used with specific blades.

    Product
    Olympus Diego Elite Console MDCONS 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2019·2019-04-24

    ProSun V3 42 Tanning Beds Recalled for Potential High UV Output

    ProSun International is recalling nine specific tanning beds due to quality control documentation discrepancies that could result in high UV output.

    Product
    ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2019·2019-04-24

    Abbott Alinity i Processing Module Recalled for Safety Interlock Defect

    Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.

    Product
    Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Burr Risk

    ICU Medical is recalling certain lots of ChemoClave Vented Vial Spikes because plastic burrs from the protective cap may contaminate the device.

    Product
    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1123-2019·2019-04-17

    Encore Medical Recalls Exprt Precision System Hip Implant Components

    Encore Medical is recalling 22 units of Exprt Precision System hip implant components due to loose or improperly seated bolts that may cause pain or require revision surgery.

    Product
    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1100-2019·2019-04-17

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a reported leak between the cardioplegia and pressure lumens.

    Product
    Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2019·2019-04-17

    DePuy Orthopaedics Recalls CORAIL AMT COXA VARA Neck Segments

    DePuy Orthopaedics is recalling CORAIL AMT COXA VARA Neck Segments because debris or material may be found behind the O-rings.

    Product
    CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2019·2019-04-17

    Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2019·2019-04-17

    LivaNova Recalls Six Sorin Heater-Cooler Systems Due to Bacteria

    LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.

    Product
    SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
    Category
    Medical Device
    Distribution
    3 states