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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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

23926–23950 of 40175

  • ModerateFDA (Devices)·Z-1647-2018·2018-05-16

    Siemens ALT Assay Reagents Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling ADVIA ALT reagent chemistry assays because they may produce inaccurate results when used with certain drugs.

    Product
    ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1766-2018·2018-05-16

    Bard POWERPORT ClearVUE Implantable Port Recalled for Incorrect Flushing Instructions

    Bard Peripheral Vascular Inc is recalling 876 units of POWERPORT ClearVUE Implantable Ports because the packaged Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1673-2018·2018-05-16

    Siemens Recalls Dimension Vista TSH Reagent Cartridges for Labeling Error

    Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions incorrectly state the biotin interference level.

    Product
    Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1761-2018·2018-05-16

    Bard POWERPORT ClearVUE isp Catheter Recalled for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 2,395 units of POWERPORT ClearVUE isp catheters because the packaged Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1660-2018·2018-05-16

    Siemens Dimension Vista Thyroxine Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.

    Product
    Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1771-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Implantable Ports

    Bard Peripheral Vascular Inc is recalling 181 POWERPORT ClearVUE Slim catheters because the included Patient ID Card has incorrect flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1743-2018·2018-05-16

    Hyphen BioMed Recalls ZYMUTEST HIA MonoStria Assay Due to Labeling Error

    Hyphen BioMed is recalling ZYMUTEST HIA MonoStria kits because the package insert incorrectly lists serum and other fluids as valid sample types.

    Product
    ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1769-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient Card Instructions

    Bard Peripheral Vascular Inc is recalling 835 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain 0.7 ml Multipacks because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1671-2018·2018-05-16

    Siemens Cardiac Troponin I Reagent Cartridge Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Cardiac Troponin I reagent cartridges because they are susceptible to interference from biotin, which is not listed in the instructions for use.

    Product
    Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2018·2018-05-16

    Siemens IMMULITE Assays Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin interference is not documented in the instructions, potentially affecting test accuracy.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2018·2018-05-16

    Siemens IMMULITE Gastrin Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1690-2018·2018-05-16

    Siemens ADVIA Centaur HBc IgM Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc IgM tests because the instructions do not list the biotin concentration limit, making the assay susceptible to interference.

    Product
    ADVIA Centaur¿ HBc IgM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2018·2018-05-16

    Diagnostic Hybrids Recalls MicroVue BAP EIA Kits Due to Leaking Bottles

    Diagnostic Hybrids, Inc. is recalling 1004 units of the MicroVue BAP EIA Model 8012 because standard bottles may have low volume or leak.

    Product
    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1696-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2018·2018-05-16

    Siemens Dimension Vista AST Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista AST assays because they may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.

    Product
    Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1773-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Implantable Port Recalled for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 10 units of POWERPORT ClearVUE Slim Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1677-2018·2018-05-16

    Siemens IMMULITE Assay Recalled Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin can interfere with results, potentially affecting patient care.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2018·2018-05-16

    Siemens IMMULITE Gastrin Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1644-2018·2018-05-16

    Mako Surgical Recalls Mislabelled Restoris MCK Tibial Baseplates

    Mako Surgical Corporation is recalling 126 Restoris MCK Tibial Baseplates due to incorrect sizing labels. The devices were distributed to facilities in the US and several international countries.

    Product
    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-1691-2018·2018-05-16

    Siemens IMMULITE 2000 BR-MA (CA15-3) Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1630-2018·2018-05-16

    Integra Manuka Honey Wound Gel Recalled for Incorrect Manufacturing Record

    Integra LifeSciences Corp. is recalling Manuka Honey Wound Gel due to an incorrect part number listed in a master manufacturing record.

    Product
    Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1631-2018·2018-05-16

    Randox Lipase Assay Recalled for Potential Contamination on Rx Instruments

    Randox Laboratories is recalling Lipase Assay kits due to potential contamination risks on Rx instruments. The recall affects specific lots distributed in West Virginia and Puerto Rico.

    Product
    Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2018·2018-05-16

    PerkinElmer Recalls NeoBase Succinylacetone Assay Solution Due to Leaking Vials

    PerkinElmer is recalling NeoBase Succinylacetone Assay Solution because leaking vials may cause minor allergic skin reactions if proper attire is not used.

    Product
    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923…
    Category
    Medical Device
    Distribution
    20 states