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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23726–23750 of 40299

  • ModerateFDA (Devices)·Z-1900-2018·2018-05-30

    Madison Polymeric Engineering Recalls Draco Enzymatic Deep-Cleaning Pads

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1910-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1919-2018·2018-05-30

    LivaNova Inspire 8 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

    LivaNova USA is recalling 70 units of Inspire 8 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.

    Product
    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1924-2018·2018-05-30

    Baxter Prismaflex Control Units Recalled for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex control units to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1911-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1922-2018·2018-05-30

    Baxter Recalls Prismaflex Systems for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex Systems to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1925-2018·2018-05-30

    Baxter Recalls Prismaflex Control Units for Firmware Update

    Baxter Healthcare is recalling 557 Prismaflex 7.XX US control units worldwide to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1912-2018·2018-05-30

    Spinal Elements Recalls Omega Lumbar Interbody Fusion Devices

    Spinal Elements is recalling 19 Omega Lumbar Interbody Fusion Devices because they were assembled with components that do not match the labeled lordosis angle.

    Product
    AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1899-2018·2018-05-30

    Madison Polymeric Engineering Recalls Flexible Endoscope Pre-Clean Kits

    Madison Polymeric Engineering is recalling First Step EP-4 Flexible Endoscope Bedside Pre-Clean Kits due to microbial contamination with Yarrowia lipolytica.

    Product
    Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)
    Category
    Medical Device
    Distribution
    40 states
  • LowFDA (Devices)·Z-1905-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 72 units of Legion CR XLPE Articular Inserts because the inner and outer packaging pouches were inadvertently sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1906-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling Legion CR XLPE High Lexion Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1907-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 47 units of Legion CR XLPE Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1920-2018·2018-05-30

    Implant Direct Legacy 4 Implant Recalled for Mislabeling

    Implant Direct Sybron Manufacturing is recalling 18 units of Legacy 4 Implants due to a mislabeled vial cap. The main label was correct, but the cap showed the wrong part number.

    Product
    ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-1918-2018·2018-05-30

    LivaNova Inspire 6 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

    LivaNova USA is recalling 42 units of Inspire 6 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.

    Product
    Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small…
    Category
    Medical Device
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-1774-2018·2018-05-23

    Abbott HeartMate 3 LVAS Implant Kit Recalled for Graft Occlusion Risk

    Abbott is recalling HeartMate 3 LVAS Implant Kits due to reports of outflow graft twist occlusions that can cause serious adverse events.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1842-2018·2018-05-23

    Medtronic Endo GIA Stapler Kits Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA stapler kits worldwide because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1838-2018·2018-05-23

    COVIDIEN Medtronic Recalls VATS Lobectomy Kits Due to Missing Sled Component

    COVIDIEN Medtronic is recalling 171,271 VATS lobectomy kits because the device may be missing a sled component. This defect can cause failure to form a staple line, leading to bleeding or leakage during surgery.

    Product
    (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1850-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling 169,775 Endo GIA universal staplers worldwide and in the US because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1815-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1863-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1862-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1826-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Universal and Universal XL staplers worldwide due to a missing sled component that may cause staple line failure, bleeding, or leakage.

    Product
    (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0) (3) BOX BOX1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0 BBR STVEIT GASTRIC B) Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2018·2018-05-23

    Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA vascular reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1701-2018·2018-05-23

    Ev3 MindFrame Capture Devices Recalled for Potential Wire Separation

    Micro Therapeutics is recalling MindFrame Capture LP Revascularization Devices because they may partially detach from the delivery wire.

    Product
    MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large…
    Category
    Medical Device
    Distribution
    0 states