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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23226–23250 of 40299

  • HighFDA (Devices)·Z-2381-2018·2018-07-18

    Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component

    Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue during surgery.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2421-2018·2018-07-18

    Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy

    Medtronic is recalling 1,867 EnTrust Escudo ICDs because they may lose high-voltage therapy without a prior alert.

    Product
    Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2018·2018-07-18

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Strips

    Immuno-Mycologics is recalling 875 units of Cryptococcal Antigen Lateral Flow Assay strips due to a defect that may cause false negative test results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2378-2018·2018-07-18

    Medline Recalls Bard MYPICC Kits Due to Potential Sterilization Failure

    Medline Industries is recalling specific Bard MYPICC Kits because one case may not have been sterilized. The product was distributed to UT.

    Product
    BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2413-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset

    Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a timing interaction that may cause a device reset.

    Product
    Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2018·2018-07-18

    Roche Vitamin D Test System Recalled for Falsely Elevated Results

    Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated and non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.

    Product
    Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,842 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2402-2018·2018-07-18

    Stryker Recalls Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.

    Product
    Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2396-2018·2018-07-18

    Stryker Recalls Nine Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling nine femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.

    Product
    Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2429-2018·2018-07-18

    bioMerieux Recalls VIDAS Analyzers and Quality Control Tests for Performance Issues

    bioMerieux is recalling VIDAS analyzers and Quality Control VIDAS tests due to pump clogging and label displacement that may cause erroneous assay results.

    Product
    BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2018·2018-07-18

    Proteus 235 Proton Beam Device Recalled for Correction Vector Loss

    Ion Beam Applications S.A. is recalling three Proteus 235 units because a software defect may cause patients to be treated in the wrong position.

    Product
    Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2018·2018-07-18

    Steris Reliance 1227 Washer/Disinfector Recalled for Chemical Alarm Failure

    Steris is recalling Reliance 1227 Washer/Disinfector units because the low chemical level alarm does not operate as intended, potentially preventing proper cleaning of patient care items.

    Product
    Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2018·2018-07-18

    Stryker Recalls Reprocessed Coronary Sinus Diagnostic Catheters

    Stryker Sustainability Solutions is recalling 2,722 reprocessed Coronary Sinus Diagnostic EP Catheters because thrombogenicity tests showed they did not meet non-thrombogenic specifications.

    Product
    Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2411-2018·2018-07-18

    Fort Defiance P2131 Steam Sterilizer Recalled for Plumbing Deposits

    Fort Defiance Industries is recalling 199 P2131 Automated Field Steam Sterilizers because stagnant water and metal interactions can create deposits that interfere with the rear sight gauge or water liquid level switch.

    Product
    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2422-2018·2018-07-18

    Cayenne Medical Recalls AperFix AM Femoral Implants Due to Breakage Risk

    Cayenne Medical Inc. is recalling 976 units of AperFix AM Femoral Implants because they may break inside the femoral socket during orthopedic use.

    Product
    AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2416-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 103 EnTrust Dual Chamber ICDs because they may lose high voltage and anti-tachycardia pacing therapy near end-of-life without prior warning.

    Product
    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2018·2018-07-18

    Ekla Recalls NOVAPLUS Pregnancy Test Kits Due to Incorrect Results

    Ekla Corporation is recalling 295 NOVAPLUS Pregnancy Cassette Devices because they may provide incorrect hCG results. The affected kits were distributed in California, Illinois, Minnesota, and Rhode Island.

    Product
    NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2414-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,604 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2018·2018-07-18

    FDA Recalls LigaSure Exact Dissector Nano Coated Due to Sterile Breach

    FDA is recalling 936 units of LigaSure Exact Dissector Nano Coated instruments because sterile pouches were found with punctures.

    Product
    LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2383-2018·2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Labeling Issues

    Arrow International is recalling 2,070 VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2387-2018·2018-07-18

    GE Medical Systems Recalls Innova IGS Fluoroscopic X-ray Systems

    GE Medical Systems is recalling 102 Innova IGS fluoroscopic X-ray systems due to a defect that may cause X-ray abort errors, resulting in the loss of imaging mode during use.

    Product
    Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2423-2018·2018-07-18

    Anika Hyalomatrix Wound Dressings Recalled for Packaging Degradation

    Anika Therapeutics is recalling Hyalomatrix wound dressings because PVC in the packaging degraded during sterilization, potentially compromising product integrity.

    Product
    Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2382-2018·2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs for Labeling Issues

    Arrow International Inc. is recalling 2,070 units of VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2385-2018·2018-07-18

    Arrow International Recalls Midline Catheter Kits Due to Labeling Issues

    Arrow International is recalling 2,070 Peripherally Inserted Midline Catheter Kits because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2410-2018·2018-07-18

    Ohio Medical Vacuum Regulator Recalled for Incomplete Quality Control Testing

    Ohio Medical Corporation is recalling 11 Vacuum Regulator units because final quality control testing was not completed before distribution.

    Product
    Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide