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

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20976–21000 of 40248

  • ModerateFDA (Devices)·Z-1208-2019·2019-05-01

    Exactech Recalls Mismarked Truliant Tibial Fit Trays for Knee Replacement

    Exactech is recalling 18 Truliant Tibial Fit Trays because they were mismarked as size 3. The devices were distributed to facilities in 10 US states.

    Product
    Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1221-2019·2019-05-01

    Maquet Edi Catheter Recalled for Incorrect Expiry Date Labeling

    Getinge is recalling Maquet Edi Catheters because the single-pack boxes are labeled with the wrong expiry date. The recall covers 17 boxes distributed in the US and several countries.

    Product
    Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1202-2019·2019-05-01

    Cytocell Recalls Aquarius CSF1R/RPS14 Probe Due to Labeling Error

    Cytocell Ltd. is recalling 19 units of the Aquarius CSF1R/RPS14 Probe Red due to an error in the chromomap labeling.

    Product
    Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1082-2019·2019-04-24

    Brainlab Spine & Trauma 3D Navigation Software Recall for Display Error

    Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.

    Product
    Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1093-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

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

    Product
    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. 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-1098-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

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

    Product
    SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. 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 contaminants…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1096-2019·2019-04-24

    ICU Medical Recalls ChemoLock Devices Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoLock devices because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (Devices)·Z-1179-2019·2019-04-24

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

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

    Product
    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1147-2019·2019-04-24

    Roche Tina-quant IgM Gen.2 Recalled for Endogenous Interference

    Roche Diagnostics is recalling Tina-quant IgM Gen.2 assays due to new endogenous interference claims that may pose a medical risk on specific analyzers.

    Product
    Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1186-2019·2019-04-24

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

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

    Product
    Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2019·2019-04-24

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

    Gyrus ACMI is recalling 21 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: BB4040XC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1182-2019·2019-04-24

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

    Gyrus ACMI is recalling 247 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 curved, Product Number:BB4040SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1094-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

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

    Product
    icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1097-2019·2019-04-24

    ICU Medical Recalls ChemoLock Vial Spikes Due to Plastic Particulate

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

    Product
    icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • HighFDA (Devices)·Z-1176-2019·2019-04-24

    ProSun Onyx 32 Sli Intensive Tanning Bed Recalled for UV Output Discrepancies

    ProSun International is recalling 31 Onyx 32 Sli Intensive tanning beds due to quality control documentation discrepancies that could result in high UV output.

    Product
    ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2019·2019-04-24

    BioFire FilmArray BCID Panel Recall for False Positive Blood Culture Results

    BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.

    Product
    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1197-2019·2019-04-24

    Abbott Alinity c Processing Module Recalled for Safety Interlock Defect

    Abbott is recalling 559 Alinity c Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.

    Product
    Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2019·2019-04-24

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

    Gyrus ACMI is recalling 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 Number: BB4000SS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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