The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

14276–14300 of 29192

  • 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-1830-2018·2018-05-23

    COVIDIEN Medtronic Recalls Endo GIA Staplers for Missing Sled Component

    COVIDIEN Medtronic is recalling approximately 171,271 Endo GIA universal staplers because a missing sled component may prevent proper staple deployment. This defect can lead to bleeding or leakage of luminal contents during surgery.

    Product
    (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1455-2018·2018-05-23

    eBars Recalls Organic Dark Chocolate Berry Bars for Peanut Allergen

    eBars is recalling Woman Organic Dark Chocolate Berry bars because testing found undeclared peanut allergen. Consumers with peanut allergies should not eat the product.

    Product
    WOMAN ORGANIC DARK CHOCOLATE BERRY bar NET WT. 1.8 OZ (51g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00418 9
    Category
    Food
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1852-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

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

    Product
    BOX PST03533 KIT APP STAPLER 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1816-2018·2018-05-23

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

    COVIDIEN MEDTRONIC is recalling 171,271 Endo GIA Universal Articulating Loading Units because a missing sled component may prevent proper staple deployment, risking bleeding or leakage during surgery.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) 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-1824-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Kits Due to 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
    Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices 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-1814-2018·2018-05-23

    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, risking bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) 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-1847-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

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

    Product
    (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1843-2018·2018-05-23

    Medtronic Recalls Bariatric Surgical Kits Due to Missing Staple Sled Component

    Medtronic is recalling 169,775 bariatric surgical kits worldwide because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Code: SGGLOGX1 ZESTAW DO BARIATRII (4)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Coder:SGGLOGX1 ZESTAW DO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1840-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal and Universal XL staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1865-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

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

    Product
    BOX VMIN ZESTAW DO VATS PODSTAWOWY 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 (Food)·F-1456-2018·2018-05-23

    Bombay Kitchen Bhavnagri Mix Recalled for Undeclared Peanuts

    Ethnic Foods, Inc. is recalling Bombay Kitchen Bhavnagri Mix because the product contains undeclared peanuts.

    Product
    Bombay Kitchen Bhavnagri Mix, packaged in a 19 oz., clear bag, UPC: 808550110206
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1825-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1821-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Reloads Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA 30mm stapler reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV) 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-1859-2018·2018-05-23

    Medtronic Endo GIA Stapler Sleeves Recalled for Missing Sled Component

    Medtronic is recalling 169,775 Endo GIA stapler sleeves worldwide due to a missing sled component that may prevent staple formation, risking bleeding or leakage.

    Product
    (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 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-1817-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for 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, risking bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1828-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Universal staplers because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) 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 (Drugs)·D-0811-2018·2018-05-23

    Milbar Recalls B Prox 10 Anti-blemish Wash Due to Microbial Contamination

    Milbar Laboratories is recalling 3,477 bottles of B Prox 10 Anti-blemish Wash due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.

    Product
    B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1866-2018·2018-05-23

    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 VWR ZESTAW DO VATS KLIN 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1820-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled

    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 60mm - 3.5mm ( Item Code 030458) 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