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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Minimum severity

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

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31601–31625 of 40449

  • ModerateFDA (Devices)·Z-0300-2016·2015-11-25

    Ameditech Recalls 11 Panel Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling 11 Panel Drug Abuse Tests because they have shown reduced reactivity. The affected products are distributed in the US and Australia.

    Product
    11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2016·2015-11-25

    TZ Medical Recalls SilverStat Hemostasis Pads Due to Labeling Discrepancy

    TZ Medical Inc. is recalling 10,180 units of SilverStat hemostasis pads because the instructions for use did not match the original FDA submission.

    Product
    SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0303-2016·2015-11-25

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Reduced Reactivity

    Ameditech is recalling ArcPoint Labs 10 Panel Dip Screen (OXY) drug tests because they have shown reduced reactivity.

    Product
    ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2016·2015-11-25

    Ameditech Recalls ProScreen Drug Panel Tests Due to Reduced Reactivity

    Ameditech is recalling ProScreen drug panel tests because they have shown reduced reactivity. The recall covers 31,530 units distributed in the US and Australia.

    Product
    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0304-2016·2015-11-25

    Ameditech Recalls CLIA RDTC 12-Panel Drug Abuse Tests for Reduced Reactivity

    Ameditech is recalling 7,482 units of CLIA RDTC 12-Panel Cup drug abuse tests because they have shown reduced reactivity. The products were distributed in the US and Australia.

    Product
    CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2016·2015-11-25

    Ameditech Recalls Thermo Fisher 6 Drug Cassettes Due to Reduced Reactivity

    Ameditech is recalling Thermo Fisher 6 Drug Cassettes because they have shown reduced reactivity. The recall affects 220 units distributed in the US and Australia.

    Product
    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0283-2016·2015-11-25

    Agfa Healthcare Recalls IMPAX CV Software for Incorrect PDF Reports

    Agfa Healthcare is recalling IMPAX CV software versions 7.8.x and 12.x because the Demographics Manager feature may generate incorrect PDF reports after physician signature.

    Product
    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0309-2016·2015-11-25

    Ameditech Recalls DrugSmart Dip Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling 160 units of DrugSmart Dip drug abuse tests because they have shown reduced reactivity. The affected products were distributed in the US and Australia.

    Product
    DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2016·2015-11-25

    Ameditech Recalls DrugSmart Drug Abuse Test Cups Due to Reduced Reactivity

    Ameditech is recalling specific DrugSmart drug abuse test cups because they have shown reduced reactivity. The affected units were distributed in the US and Australia.

    Product
    DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2016·2015-11-25

    Ameditech Recalls Premier Clia Waived 12 Panel Tilt Cup Drug Tests

    Ameditech is recalling Premier Clia Waived 12 Panel Tilt Cup drug tests because they have shown reduced reactivity.

    Product
    Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2016·2015-11-25

    Ameditech Recalls 6 Panel Drug Detection Cups Due to Reduced Reactivity

    Ameditech is recalling 2,240 units of 6 Panel Cup Body and Lid drug tests because they have shown reduced reactivity.

    Product
    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0307-2016·2015-11-25

    Ameditech Recalls DrugSmart 10 Test Cups Due to Reduced Reactivity

    Ameditech is recalling DrugSmart 10 Test Cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2016·2015-11-25

    Ameditech Recalls 10-Panel Pipette Drug Screen Due to Reduced Reactivity

    Ameditech is recalling 10-Panel Pipette Drug Screen tests because they have shown reduced reactivity. The recall affects 200 units distributed in the US and Australia.

    Product
    10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0305-2016·2015-11-25

    Ameditech Recalls DrugCheck Pipette 10 Drug Tests Due to Reduced Reactivity

    Ameditech is recalling 70 units of DrugCheck Pipette 10 Drug Tests because they have shown reduced reactivity. The affected tests were distributed in the US and Australia.

    Product
    DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2016·2015-11-25

    Ameditech Recalls 12-Panel Dip Drug Screens Due to Reduced Reactivity

    Ameditech is recalling 12-Panel Dip Drug Screens with adulterant because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0291-2016·2015-11-25

    Baxter HomeChoice APD Systems Recalled for Loud Operating Sounds

    Baxter is recalling HomeChoice and HomeChoice Pro APD systems due to loud operating sounds. The devices function correctly, but the noise is unacceptable to users.

    Product
    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0212-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices due to complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0248-2016·2015-11-18

    Maquet Universal Frame Recalled Due to Thromboembolic Event Reports

    Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.

    Product
    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0211-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Wire Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0247-2016·2015-11-18

    Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events

    Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.

    Product
    Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0251-2016·2015-11-18

    Shimadzu C-arm Table Recall Due to Interference Risk

    Shimadzu Medical Systems is recalling 26 C-arm Tables because the C-arm may interfere with the table top under certain circumstances.

    Product
    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0254-2016·2015-11-18

    GE Healthcare Recalls MRI Scanners Due to Potential SAR Limit Exceedance

    GE Healthcare is recalling 756 MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits during head or neck scans.

    Product
    GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2016·2015-11-18

    GE Healthcare Recalls Signa 3.0T MRI Systems Due to SAR Display Error

    GE Healthcare is recalling 19 Signa 3.0T MRI systems because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2016·2015-11-18

    Teleflex Medical Recalls Rusch Flexi-slip Tracheal Tube Stylets

    Teleflex Medical is recalling Rusch Flexi-slip tracheal tube stylets because the plastic coating may split or break off.

    Product
    Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2016·2015-11-18

    Stryker Vitallium Femoral Heads Recalled Due to Assembly Failure

    Stryker Howmedica Osteonics Corp. is recalling 201 Vitallium femoral heads because they could not be assembled with their corresponding stems during surgery.

    Product
    Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide