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.

Filters

Agency

Category

Minimum severity

Clear filters

23176–23200 of 40299

  • HighFDA (Devices)·Z-2461-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture products because a packaging design issue may allow needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2463-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline suture products because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2479-2018·2018-07-25

    Hitachi Oasis MRI Systems Recalled for Exposed Belt Hazard

    Hitachi Medical Systems America Inc is recalling 264 Oasis MRI systems because an exposed stainless steel belt can cause finger cuts.

    Product
    Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2018·2018-07-25

    GE Medical Systems Recalls T2100 Microflex Drive Treadmill Units

    GE Medical Systems is recalling T2100 Microflex Drive Treadmills because unaddressed spare parts may cause uncontrolled walking belt motion during stress tests.

    Product
    T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 372 units of Proline Suture Blue 18" 7-0 because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2462-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles to perforate the package, posing risks of soft tissue injury or infection.

    Product
    PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2457-2018·2018-07-25

    Ethicon Recalls Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture units because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2316-2018·2018-07-25

    Wescam MX-10 Surveillance Laser System Recalled for Ocular Hazard

    Wescam Inc is recalling 29 MX-10 surveillance laser systems because the ocular hazard distance is longer than specified, posing a risk of eye exposure.

    Product
    MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2448-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline suture products because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2437-2018·2018-07-25

    Siemens Dimension Vista MULTI 1 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent due to a potential defect in the vial cap septum that may cause inaccurate test results.

    Product
    Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2447-2018·2018-07-25

    NewDeal TIBIAXYS Medical Device Recalled Due to Infection Risk

    NewDeal SA is recalling TIBIAXYS devices because use may cause superficial or deep infections requiring antibiotic treatment or device removal.

    Product
    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2456-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 300 units of Proline Suture 30" 6-0 Blue because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.

    Product
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2439-2018·2018-07-25

    Opgen Recalls AdvanDx QuickFISH Slides Due to Diminished Performance

    Opgen Inc is recalling AdvanDx QuickFISH Slides because they may show diminished performance before their expiration date.

    Product
    AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2435-2018·2018-07-25

    Edwards SAPIEN 3 Transcatheter Heart Valve Recalled for Incorrect Size Labeling

    Edwards Lifesciences is recalling one SAPIEN 3 Transcatheter Heart Valve because it was packaged with the incorrect valve size relative to the label.

    Product
    Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2480-2018·2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches

    Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2496-2018·2018-07-25

    Philips Ingenuity Digital PET/CT System Recall for Pallet Assembly Defect

    Philips is recalling 32 Ingenuity Digital PET/CT Systems because a block connecting the patient pallet to the couch may be assembled incorrectly, potentially causing a misaligned screw.

    Product
    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2482-2018·2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches

    Cardinal Health is recalling Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2018·2018-07-25

    Stryker Recalls Reprocessed Harmonic Ace Shears Due to Error Code

    Stryker is recalling 180 reprocessed Harmonic Ace shears because they may display an error code preventing use.

    Product
    Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2436-2018·2018-07-25

    Siemens Dimension Vista CTNI Sample Diluent Recalled for Defective Cap Septum

    Siemens Healthcare Diagnostics is recalling 1,446 units of Dimension Vista CTNI Sample Diluent because a defective cap septum may cause erroneously elevated test results.

    Product
    Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2431-2018·2018-07-25

    Medtronic Vectris Trial Screening Lead Kit Recalled for Needle Defect

    Medtronic is voluntarily recalling Vectris Trial Screening Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.

    Product
    Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2430-2018·2018-07-25

    Valeris Medical Recalls Apollo XT Suture Anchors Due to Material Mislabeling

    Valeris Medical is recalling 113 Apollo XT Suture Anchors because the labels incorrectly identified the material as titanium instead of PEEK.

    Product
    Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2018·2018-07-25

    Fx Solutions Proton Beam Therapy Heads Recalled for Blister Breach

    Fx Solutions is recalling specific proton beam therapy heads due to a breach in the external blister packaging.

    Product
    Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2018·2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches

    Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2469-2018·2018-07-25

    Fx Solutions Offset Heads Recalled for Blister Breach

    Fx Solutions is recalling specific lots of Humelock Offset Heads due to a breach in the external blister packaging.

    Product
    Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2018·2018-07-25

    Health Harmony Mobile App Recalled for Data Synchronization Delays

    Intel-GE Care Innovations LLC is recalling the Health Harmony Mobile application because patient data sometimes failed to sync with the backend database in a timely manner.

    Product
    Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from…
    Category
    Medical Device
    Distribution
    Distributed nationwide