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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25376–25400 of 40357

  • HighFDA (Devices)·Z-0270-2018·2018-01-03

    L3 Security Cabinet X-ray System Recalled for Shielding Gaps

    L3 Security & Detection is recalling 471 Examiner 3DX 6000 cabinet X-ray systems used for airline baggage screening due to shielding gaps that may cause excessive X-ray emissions.

    Product
    L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2018·2018-01-03

    Accuray TomoHD System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.

    Product
    TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0292-2018·2018-01-03

    Philips IntelliVue Patient Monitors Recalled for Distorted ST-Segment Display

    Philips is recalling specific IntelliVue patient monitors and measurement servers because they may display distorted ST-segments during 12-lead ECG monitoring.

    Product
    IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2018·2018-01-03

    Medline Recalls Sterile Elastic Esmark Bandages Due to Sterilization Failure

    Medline Industries is recalling 5,722 units of sterile elastic bandages because they may not have been properly sterilized.

    Product
    Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2018·2018-01-03

    Orthofix Power Drill Torque Limiter Recalled Due to Breakage Risk

    Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.

    Product
    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0273-2018·2018-01-03

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.

    Product
    VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0290-2018·2018-01-03

    Remel Shigella sonnei Agglutinating Serum Recalled for Failure to Agglutinate

    Remel Inc is recalling Shigella sonnei Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time.

    Product
    Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0285-2018·2018-01-03

    Randox HbA1c Reagent Recalled for Low Calibration Absorbance

    Randox Laboratories is recalling 90 kits of HbA1c reagent (Batch 414553) due to low calibration absorbance that may affect performance.

    Product
    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0264-2018·2017-12-27

    BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2018·2017-12-27

    BioMerieux Recalls ETEST OXACILLIN Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2018·2017-12-27

    Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 356 GemLock RHD2.5 Hex Drivers because a manufacturing defect may prevent the tool from properly engaging dental fixtures.

    Product
    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2018·2017-12-27

    Rezum System Recall Due to Potential Needle Bond Failure During Prostate Treatment

    NxThera is recalling 113 Rezum System units because the needle bond may fail during deployment, posing a risk of injury to patients.

    Product
    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0257-2018·2017-12-27

    Terumo Overpressure Safety Valve Recall Due to No Flow Reports

    Terumo CVS is recalling custom surgical kits containing Overpressure Safety Valves due to reports of no flow through the valve.

    Product
    Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0274-2018·2017-12-27

    Qiagen QIAamp DSP Virus Kit Recalled for Decreased Performance

    Qiagen is recalling specific lots of the QIAamp DSP Virus Kit because they may result in decreased performance in analytic workflows.

    Product
    QIAamp DSP Virus Kit Cat. No. 60704
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0266-2018·2017-12-27

    Medacta Recalls GMK Knee System Inserts Due to Screw Back-Out Risk

    Medacta is recalling 12,768 GMK knee system inserts nationwide due to a reported 0.1% occurrence rate of post-operative screw back-out.

    Product
    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2018·2017-12-27

    Terumo Overpressure Safety Valve Recalled Due to No Flow Reports

    Terumo CVS is recalling 297,222 Overpressure Safety Valves worldwide after receiving reports of no flow through the device.

    Product
    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0280-2018·2017-12-27

    Zimmer Dental Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 30 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2018·2017-12-27

    Zimmer Dental Tapered Screw-Vent Implant Surgical Kits Recalled for Geometry Defect

    Zimmer Dental Inc. is recalling 891 Tapered Screw-Vent Implant System surgical kits because a manufacturing defect in the driver's hex feature may prevent proper engagement with dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0255-2018·2017-12-27

    Philips Medical Imaging Systems Recalled for Measurement Export Error

    Philips is recalling 157 medical imaging systems because a software option prevents correct export of measurement data to external destinations.

    Product
    Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0271-2018·2017-12-27

    C.R. Bard Recalls Medivance ArcticGel Small Pad Kits Due to Peeling

    C.R. Bard is recalling 24 Medivance ArcticGel Small Pad Kits because the hydrogel is peeling from the pads. The affected units were distributed to 10 US states.

    Product
    Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0263-2018·2017-12-27

    Invivo Recalls Xper Flex Cardio Physiomonitoring Systems Due to Communication Issues

    Invivo Corporation is recalling 4,535 Xper Flex Cardio Physiomonitoring systems because of intermittent communication between the host system and the device.

    Product
    Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0275-2018·2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling 2 units of Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0267-2018·2017-12-27

    C.R. Bard Recalls I-125 QuickLink Cartridges Due to Incorrect Quantity

    C.R. Bard is recalling I-125 QuickLink Cartridges because the quantity of seeds sent in shipments was incorrect.

    Product
    I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0278-2018·2017-12-27

    Philips HeartStart MRx Defibrillators Recalled for EtCO2 Module Contamination

    Philips is recalling 20 HeartStart MRx defibrillators because EtCO2 module contamination may prevent the device from displaying the CO2 waveform.

    Product
    Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
    Category
    Medical Device
    Distribution
    0 states