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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19601–19625 of 27647

  • HighFDA (Devices)·Z-2143-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2017·2017-05-31

    Datascope Recalls Intra-Aortic Balloon Catheters Due to Tip Seal Leak Failures

    Datascope is voluntarily removing 996 units of SENSATION PLUS Intra-Aortic Balloon Catheters due to internal pressure testing failures related to tip seal leaks.

    Product
    SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2017·2017-05-31

    CORPAK Recalls CORFLO PEG Adaptor Repair Kits Due to Breakage Risk

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break under stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe.…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2157-2017·2017-05-31

    Beckman Coulter UniCel DxH 800 Recalled for Potential Data Errors

    Beckman Coulter is recalling UniCel DxH 800 systems because a software issue may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2017·2017-05-31

    Beckman Coulter UniCel DxH 600 Recall for Erroneous WBC Differential Results

    Beckman Coulter is recalling UniCel DxH 600 systems due to a software issue that may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2017·2017-05-31

    Medtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices

    Medtronic is recalling specific MRI-conditional CRT-D devices due to an unexpected transient mode switch behavior detected during systems testing.

    Product
    Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains

    Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2017·2017-05-31

    CORPAK CORFLO PEG Kit Recall Due to Potential Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Kits because the ENFit connector stem may break unexpectedly under stress.

    Product
    CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2133-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2017·2017-05-31

    Merge Cardio software recalled for incorrect fetal measurement data retrieval

    Merge Healthcare is recalling Merge Cardio software versions 10.0 through 10.1.2 because the software may display incorrect fetal measurements by pulling data from prior pregnancies.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2141-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2017·2017-05-31

    Stryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk

    Stryker is recalling Hoffmann LRF Safety Clips because they may loosen from the Quick Release mechanism on Transport Struts.

    Product
    Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2038-2017·2017-05-24

    Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues

    Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2037-2017·2017-05-24

    Abbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Trek RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2112-2017·2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.

    Product
    OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2017·2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin Group is recalling specific implantable defibrillators because battery depletion may be undetectable, posing a risk to patients.

    Product
    PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2039-2017·2017-05-24

    Abbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheters because the protective sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2097-2017·2017-05-24

    Ion Beam Applications Recalls Two Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.

    Product
    Proton therapy system -Proteus 235 aka Proteus Plus. A medical 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
    1 state
  • SevereFDA (Devices)·Z-1926-2017·2017-05-24

    Magellan LeadCare Ultra Blood Lead Test Kits Recalled for Inaccurate Results

    Magellan Diagnostics is recalling LeadCare Ultra Blood Lead Test Kits because they may generate falsely low lead concentrations when used with specific Becton Dickinson EDTA Vacutainer tubes.

    Product
    Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1925-2017·2017-05-24

    Magellan LeadCare Blood Analyzer Recall for Falsely Low Lead Results

    Magellan Diagnostics is recalling LeadCare Ultra Blood Analyzers because they may generate falsely low lead concentrations when used with specific Becton Dickinson collection tubes.

    Product
    Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
    Category
    Medical Device
    Distribution
    Distributed nationwide