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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

29101–29125 of 40449

  • HighFDA (Devices)·Z-2815-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2016·2016-09-21

    Howmedica Recalls AccuLIF PL Cages Due to Height Reduction

    Howmedica Osteonics Corp. is recalling AccuLIF PL Cages because some implants have shown a reduction in height greater than 1 mm after surgery.

    Product
    AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2823-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2016·2016-09-21

    Arrow Select Kit Recall Due to Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 Arrow Select Kit units due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2771-2016·2016-09-21

    Arrow International Recalls Select Kit Products Due to Molding Abnormality

    Arrow International is recalling 6,121 units of Select Kit products due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2782-2016·2016-09-21

    Trinity Biotech Captia Measles IgM Test Kit Recalled for QC Failure

    Clark Laboratories is recalling specific lots of the Captia Measles IgM test kit because the product failed quality control stability testing.

    Product
    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2780-2016·2016-09-21

    Mentor Artoura Breast Tissue Expander Recall for Packaging Error

    Mentor Texas, LP. is recalling 48 Artoura Breast Tissue Expanders because CPX4 devices may have been packaged in Artoura boxes.

    Product
    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2781-2016·2016-09-21

    Mentor CPX4 Breast Tissue Expander Recall Due to Packaging Error

    Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders because they may have been packaged in the wrong box.

    Product
    CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2792-2016·2016-09-21

    Stryker Recalls Mislabelled Femoral and Tibial Nails

    Stryker Howmedica Osteonics Corp. is recalling specific femoral and tibial nails that were incorrectly labeled and distributed to California.

    Product
    Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2777-2016·2016-09-21

    Integra Meshed Dermal Regeneration Template Recalled for Calculation Error

    Integra LifeSciences is recalling 14 packages of Meshed Dermal Regeneration Template due to an incorrect calculation of peel strength test results.

    Product
    Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2793-2016·2016-09-21

    Siemens Syngo Plaza PACS Recall for Measurement Display Suffix

    Siemens is recalling 101 Syngo Plaza PACS systems because a suffix on DICOM images may indicate that displayed measurements differ from actual values.

    Product
    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2770-2016·2016-09-21

    Sysmex Fluorocell PLT Reagent Recalled for Potential Low Platelet Results

    Sysmex America Inc is recalling Fluorocell PLT reagent because it may produce falsely low platelet results on Sysmex XN-Series analyzers.

    Product
    Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2791-2016·2016-09-21

    Stryker Recalls Mislabelled T2 Supracondylar Nail System

    Stryker Howmedica Osteonics Corp. is recalling one unit of the T2 Supracondylar Nail System because it was incorrectly labeled and distributed.

    Product
    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2794-2016·2016-09-21

    Siemens Syngo.Plaza VB 10 A PACS Recall for Measurement Suffix Display

    Siemens is recalling 101 Syngo.Plaza VB 10 A image processing systems because a suffix on DICOM images may indicate that displayed measurement values differ from real values.

    Product
    Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2773-2016·2016-09-21

    Arrow Single-Lumen Catheters Recalled for Packaging Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Single-Lumen Catheters due to a molding abnormality in the packaging component supplied by a vendor.

    Product
    Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2829-2016·2016-09-21

    AirStrip Sense4Baby Fetal Monitor Recalled for Detaching Belt Clip

    AirStrip Technologies is recalling 42 Sense4Baby Model C fetal monitors because the belt clip may detach, exposing electronic components.

    Product
    AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2772-2016·2016-09-21

    Arrow Select Kit Ultrasound Catheters Recalled for Packaging Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Select Kit ultrasound catheters due to a component molding abnormality in the packaging.

    Product
    Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2775-2016·2016-09-21

    Thermo Fisher Recalls Endura MD Mass Spectrometer Software Due to Data Accuracy Defect

    Thermo Fisher is recalling Endura MD Mass Spectrometer software versions 1.0 and 1.0 SP1 because a defect affects data accuracy.

    Product
    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2776-2016·2016-09-21

    Biosense Webster Recalls CARTO 3 EP Navigation Systems in China

    Biosense Webster is voluntarily re-installing 338 CARTO 3 EP Navigation Systems in China, Hong Kong, and Brazil that were moved without required testing.

    Product
    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2804-2016·2016-09-21

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Calibrator Kit 31

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 31, Lot 3155, because an incorrect value on the Assay Data Disks prevents successful calibration of the HbA1c assay.

    Product
    The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2779-2016·2016-09-21

    Biomerieux Recalls VIDAS NT-pro-BNP Kits Due to Packaging Error

    Biomerieux is recalling 229 VIDAS NT-pro-BNP kits because they contain the incorrect number of control vials.

    Product
    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2778-2016·2016-09-21

    Alere LDX Optical Check Cassettes Recalled for Incorrect Expiration Date

    Alere San Diego, Inc. is recalling LDX Optical Check Cassettes because the expiration date on the magnetic strip does not match the labeled date.

    Product
    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2701-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2700-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening

    MicroPort Orthopedics is recalling 77 Advance II Modular Tibial Bases because they are experiencing higher than expected revision rates due to component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee…
    Category
    Medical Device
    Distribution
    0 states