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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23001–23025 of 40175

  • LowFDA (Devices)·Z-2574-2018·2018-08-08

    Diamedix EBV Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 147 units of the Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit due to a gel-like contaminant that may affect product performance.

    Product
    Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-2598-2018·2018-08-08

    BD FACS Universal Loader Recalled for Insufficient Locking Mechanism

    Becton, Dickinson and Company is recalling 8 BD FACS Universal Loader devices because the solenoid plunger tip is too short to lock securely during use.

    Product
    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It…
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2548-2018·2018-08-01

    Cayenne Medical Recalls AperFix Femoral Implant Coring Removal Drills

    Cayenne Medical Inc. is recalling specific models of the AperFix Femoral Implant Coring Removal Drill due to a trend of premature wear and breakage identified in 2010.

    Product
    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2018·2018-08-01

    DePuy CORAIL Femoral Stems Recalled Due to Incorrect Size Labeling

    DePuy Orthopaedics is recalling two lots of CORAIL femoral stems labeled as Size 11 but actually Size 12 due to fit and mechanical risks.

    Product
    CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2498-2018·2018-08-01

    Philips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2018·2018-08-01

    Siemens AXIOM Artis Angiography System Recalled for Defective Sealing

    Siemens is recalling six AXIOM Artis angiography systems in the US due to a defective sealing that could allow coolant to leak into electrical parts.

    Product
    AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2517-2018·2018-08-01

    Implantcast Recalls Hip Implant Inserts Due to Retaining Ring Mounting Risk

    Implantcast GmbH is recalling specific 2M insert 15degree orthopedic hip implant components because the retaining ring may be incorrectly mounted.

    Product
    2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2542-2018·2018-08-01

    Life Technologies Recalls Gibco CTS OpTmizer T Cell Expansion Medium

    Life Technologies is recalling Gibco CTS OpTmizer T Cell Expansion Serum Free Medium due to compromised fill port tube seals that may allow mold growth.

    Product
    Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2539-2018·2018-08-01

    Ad-Tech Drill Sleeve Guides Recalled Due to Raw Material Tolerance Defect

    Ad-Tech Medical Instrument Corporation is recalling 65 Drill Sleeve Guides because raw material diameter was under tolerance, which could cause drill bits to seize during surgery.

    Product
    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2018·2018-08-01

    Ethicon Recalls PDS Plus Antibacterial Sutures Due to Tensile Strength Defect

    Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2535-2018·2018-08-01

    Elekta Recalls HexaPOD evo RT Couch Top for Positioning Errors

    Elekta, Inc. is recalling 725 HexaPOD evo RT Couch Top devices because they may tilt incorrectly after specific workflows, leading to improper patient positioning during radiation therapy.

    Product
    HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Tissue Culture Medium Due to Seal Defect

    Life Technologies is recalling Gibco DMEM tissue culture medium because compromised seal integrity may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2543-2018·2018-08-01

    Life Technologies Recalls GIBCO CTS AIM V Serum-Free Media Due to Seal Defect

    Life Technologies is recalling 141 units of GIBCO CTS AIM V Serum-Free Media because compromised seal integrity may allow media to leak and grow mold.

    Product
    GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2549-2018·2018-08-01

    FDA Recalls Prevent G Safety Winged Blood Collection Sets Due to Leaks

    Guangzhou Improve Medical Instruments Co., Ltd. is recalling 200,000 Prevent G Safety Winged Blood Collection Sets in Kansas due to leak complaints.

    Product
    Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2537-2018·2018-08-01

    Forte Automation Patient Positioning System Recalled for Communication Failures

    Forte Automation Systems is recalling 13 patient positioning systems in California due to periodic communication failures with the accuracy filter that may not be indicated to the operator.

    Product
    Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2546-2018·2018-08-01

    Life Technologies Recalls Gibco RPMI 1640 Medium Due to Seal Integrity Issues

    Life Technologies is recalling Lot 1930752 of Gibco RPMI 1640 Medium because compromised fill port tube seals may allow media to leak and mold to grow.

    Product
    Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2527-2018·2018-08-01

    GE MR Surgical Suite Option Recalled for Patient Transfer Mechanism Defect

    GE Medical Systems is recalling 54 MR Surgical Suite Option units because a defect in the table transfer release may cause an unexpected loss of function in the patient transfer mechanism.

    Product
    MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2018·2018-08-01

    Roche Recalls cobas m 511 Hematology Analyzer for Discrepant Results

    Roche Diagnostics Hematology is recalling 17 cobas m 511 integrated hematology analyzers due to discrepant results in patients with severe microcytic anemia.

    Product
    cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2545-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Tissue Culture Medium Due to Seal Defect

    Life Technologies is recalling 91 units of Gibco DMEM tissue culture medium because compromised fill port seals may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2526-2018·2018-08-01

    Siemens Artis zee Systems Recalled for Defective Cooling Unit Seals

    Siemens is recalling Artis zee angiography systems with specific Laird cooling units due to defective seals that may allow coolant to leak into electrical parts, potentially causing sudden system shutdowns.

    Product
    Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2533-2018·2018-08-01

    Ethicon Recalls PDS Plus Antibacterial Sutures for Tensile Strength Defects

    Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.

    Product
    PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2547-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Cell Culture Medium Due to Seal Defect

    Life Technologies is recalling 70 units of Gibco DMEM cell culture medium because compromised fill port seals may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states