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)

Clear filters

33226–33250 of 40325

  • HighFDA (Devices)·Z-1398-2015·2015-04-15

    Siemens QuikLYTE Dilution Check Recalled for Potential Result Bias

    Siemens Healthcare Diagnostics is recalling QuikLYTE Dilution Check units due to a potential positive bias that could cause elevated patient results for sodium, potassium, and chloride.

    Product
    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1397-2015·2015-04-15

    CooperSurgical Infant Transport Mattress Recalled for Missing Expiration Date

    CooperSurgical is recalling TransWarmer Infant Transport Mattresses because they lack expiration dates, potentially failing to meet specifications.

    Product
    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Arm Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Surgical System arm drapes due to a cloudy, waxy appearance that may transfer to patients or cause tearing.

    Product
    da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1385-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Head Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Head Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1378-2015·2015-04-15

    Carestream CS 8100 3D Dental X-Ray Devices Recalled for Unexpected Head Descent

    Carestream Health is recalling 470 CS 8100 3D dental X-ray units because the device head may descend unexpectedly, posing a risk of injury to patients or operators.

    Product
    CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1394-2015·2015-04-15

    Toshiba INFX-8000V Interventional Angiography System Recall for Brake Defect

    Toshiba is recalling 28 INFX-8000V Interventional Angiography Systems because the table base rotational brake may not engage when force is applied to the table top.

    Product
    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Camera Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1384-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Monitor Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Vision-Cart Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1381-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci S Camera Arm Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1408-2015·2015-04-15

    VasoNova Vascular Positioning System G4 Console Recalled for Standard Noncompliance

    VasoNova is recalling 17 Vascular Positioning System G4 Consoles due to noncompliance with IEC Standard 60101-1-1.

    Product
    VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2015·2015-04-15

    Bacterin OsteoSponge Instrument Kits Recalled for Sterilization Errors

    Bacterin International is recalling 63 Instrument Kits for OsteoSponge SC grafts because the instructions for use contain incorrect sterilization parameters.

    Product
    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic…
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1379-2015·2015-04-15

    TEM Systems Recalls ROTROL P Control Vials Due to Partial Filling

    TEM Systems Inc is recalling specific lots of ROTROL P Control vials because some were found to be partially filled.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Arm Drapes due to a cloudy appearance and potential to tear or transfer waxy substance to patients.

    Product
    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1387-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Instrument Arm Drapes Due to Defects

    Intuitive Surgical is recalling da Vinci S/Si Instrument Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1383-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Patient-Cart Monitor Drapes

    Intuitive Surgical is recalling da Vinci S Patient-Cart Monitor Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1388-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Camera Arm Drapes for Defects

    Intuitive Surgical is recalling da Vinci S/Si Camera Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1399-2015·2015-04-15

    Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error

    Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.

    Product
    ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in…
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1403-2015·2015-04-15

    Biomerieux Recalls Vitek 2 AST-P641 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P641 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1402-2015·2015-04-15

    Biomerieux Recalls Vitek 2 AST-P640 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P640 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1401-2015·2015-04-15

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P635 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended organism.

    Product
    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1362-2015·2015-04-08

    Pega Medical Recalls GAP Nail 4.8mm Due to Distal Screw Hole Failures

    Pega Medical Inc. is recalling 7 units of the 4.8mm GAP Nail because of failures at the distal cortical screw holes, primarily in patients with specific bone conditions.

    Product
    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1356-2015·2015-04-08

    Medtronic Temporary Pacemaker Recalled for Battery Connection Failure

    Medtronic is recalling 6,040 Model 5392 temporary pacemakers because specific AA batteries may fail to connect, potentially stopping pacing therapy.

    Product
    Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1370-2015·2015-04-08

    BD FACSCalibur Instruments Recalled for Incorrect Circuit Breaker Amperage

    BD Biosciences is recalling 72 BD FACSCalibur instruments because some have circuit breakers with incorrect amperage ratings, which may fail to open during over-current situations.

    Product
    BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1357-2015·2015-04-08

    DePuy RECLAIM Hip Implant Inserter Adaptor Recalled for Fracture Risk

    DePuy Orthopaedics is recalling 54 units of the RECLAIM Assembled Implant Inserter Adaptor because the instrument may fracture during surgery, potentially leaving plastic pieces in the patient.

    Product
    RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1355-2015·2015-04-08

    Boston Scientific Recalls Biliary Drainage Catheters Due to Fragmentation Risk

    Boston Scientific is recalling specific lots of Expel Drainage Catheters because they may fragment after implantation, potentially requiring additional medical procedures to remove the pieces.

    Product
    Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
    Category
    Medical Device
    Distribution
    4 states