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 27682

  • HighFDA (Devices)·Z-2237-2017·2017-06-14

    ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks

    ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.

    Product
    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2230-2017·2017-06-14

    ConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect

    ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.

    Product
    Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2235-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns

    ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.

    Product
    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2263-2017·2017-06-14

    Arrow Central Venous Catheter Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling 43,394 units of ARROWg+ard Blue PLUS Two-Lumen Central Venous Catheterization Kits due to safety cover disengagement and needlestick injury reports.

    Product
    ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2017·2017-06-14

    Zimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability

    Zimmer CAS is voluntarily recalling 10 Sesamoid Plasty workstations because the top of the unit may fall over during disassembly.

    Product
    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2247-2017·2017-06-14

    Medtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect

    Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.

    Product
    KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2151-2017·2017-06-07

    Abbott Absorb Bioresorbable Vascular Scaffold Recalled for Elevated Adverse Event Rates

    Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.

    Product
    Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2175-2017·2017-06-07

    Philips NMT Patient Cable Recall for Potential Skin Burn Risk

    Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.

    Product
    NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-2179-2017·2017-06-07

    GE Healthcare Recalls Patient Steps on RFX, Legacy, and Precision 500D Systems

    GE Healthcare is recalling 2,380 patient steps for RFX, Legacy, and Precision 500D systems because they may detach from the table, posing a fall risk.

    Product
    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2017·2017-06-07

    Vascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect

    Vascular Solutions, Inc. is recalling 4,110 Dolphin Inflation Devices due to a potential sterile barrier defect that could lead to microbial contamination and infection.

    Product
    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2176-2017·2017-06-07

    AbbVie Recalls 673 PEG Kits Due to Sterility Concerns

    AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.

    Product
    AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2017·2017-06-07

    Cardinal Digital Bariatric Scales Recalled Due to Seat Failure Risk

    Cardinal Scale Mfg Co is recalling 975 digital bariatric scales because a seat may fail unexpectedly, posing an injury risk.

    Product
    Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2017·2017-06-07

    Zimmer Biomet Recalls Reusable Orthopedic Instruments Due to Durability Concerns

    Zimmer Biomet is recalling reusable instruments for knee, hip, trauma, and extremities because their durability characteristics were not established.

    Product
    Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2017·2017-06-07

    KCI USA Recalls 1000 ml Canisters for Negative Pressure Wound Therapy Systems

    KCI USA is recalling 5,385 cases of 1000 ml canisters for InfoV.A.C. and V.A.C.ULTA systems due to a potential sterile barrier breach.

    Product
    1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2017·2017-06-07

    Hans Pausch Uroview FD Fluoroscopic X-ray System Recalled for Footswitch Safety Issue

    Hans Pausch is recalling 10 Uroview FD fluoroscopic X-ray systems because the footswitch used to activate radiation is part of the safety circuit.

    Product
    Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2017·2017-06-07

    Ethicon Endopath ETS-FLEX Endoscopic Linear Cutter Recalled for Gear Failure Risk

    Ethicon Endo-Surgery Inc is recalling 792 units of the Endopath ETS-FLEX Endoscopic Articulating Linear Cutter due to a risk of pinion gear failure under extreme use cases.

    Product
    Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2215-2017·2017-06-07

    Zimmer Biomet Recalls AFFIXUS Hip Fracture Nail Due to Sizing Defect

    Zimmer Biomet is recalling 33,500 AFFIXUS Hip Fracture Nail units worldwide because certain undersized specifications may prevent the nail from properly engaging with the targeting jig.

    Product
    AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2119-2017·2017-05-31

    EBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity

    EBI Patient Care, Inc. is recalling 33 SpF-PLUS Implantable Stimulators due to higher than allowed cytotoxicity levels found during routine process monitoring.

    Product
    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2052-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2051-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall

    St. Jude Medical is updating software and hardware for HeartMate II LVAS devices to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2053-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2118-2017·2017-05-31

    EBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity

    EBI Patient Care is recalling 33 SpF-XL IIB implantable stimulators because routine monitoring found higher than allowed cytotoxicity levels.

    Product
    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2017·2017-05-31

    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 the risk of infection.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 15FR 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 wound drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 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, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide