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.

14301–14325 of 29192

  • SevereFDA (Devices)·Z-1822-2018·2018-05-23

    Medtronic Endo GIA Stapler Reloads Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA 30mm stapler reloads because a missing sled component may cause staple failure, leading to bleeding or leakage.

    Product
    Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1837-2018·2018-05-23

    Medtronic Endo GIA Universal Bypass Kits Recalled for Missing Sled Component

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

    Product
    KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1849-2018·2018-05-23

    Medtronic Recalls Bariatric Staplers Due to Missing Sled Component

    Medtronic is recalling specific bariatric stapler kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03533 KIT APP STAPLER (Item Number: PST03403) Product Usage: The Endo GIA universal and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1832-2018·2018-05-23

    COVIDIEN Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled

    COVIDIEN Medtronic is recalling Endo GIA universal stapler kits because a missing sled component may prevent proper staple deployment, risking bleeding or leakage.

    Product
    BOX KIT00713 KIT BY PASS 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 (Drugs)·D-0840-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling specific lots of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1839-2018·2018-05-23

    Medtronic Recalls Bypass Kits Due to Missing Stapler Component

    Medtronic is recalling 171,271 Endo GIA Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) 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-1831-2018·2018-05-23

    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
    KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1445-2018·2018-05-23

    eBars Recalls Organic Chocolate Peanut Bars for Undeclared Almonds

    eBars is recalling FOCUS Organic Chocolate Peanut bars because they contain undeclared almonds. The recall affects 33,115 units shipped to multiple states.

    Product
    FOCUS ORGANIC CHOCOLATE PEANUT bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00417 2
    Category
    Food
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1834-2018·2018-05-23

    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, potentially causing bleeding or leakage.

    Product
    BOX KIT1171C KIT LAP CYSTECTOMY 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
  • SevereUSDA FSIS·039-2018·2018-05-18

    Hempler Foods Recalls Pepperoni Sticks Due to Undeclared Milk Allergen

    Hempler Foods Group is recalling ready-to-eat pepperoni sticks because they contain milk, a known allergen, that is not declared on the label.

    Product
    Hempler Foods Group LLC — Hempler Foods Group Recalls Ready-To-Eat Pepperoni Sticks Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·18V365000·2018-05-18

    Van-Con Recalls One 2016 School Bus Due to Roof Panel Bonding Defect

    Van-Con is recalling one 2016 33803 Dual Rear Wheel school bus because roof panel seams were not correctly bonded, posing an increased injury risk in a crash.

    Product
    VAN-CON — VAN-CON 33803 DUAL REAR-WHEEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V332000·2018-05-17

    Chrysler Recalls Vehicles for Cruise Control Disengagement Defect

    Chrysler is recalling over 4.8 million vehicles because a wiring short may prevent the cruise control system from disengaging, increasing crash risk.

    Product
    JEEP — JEEP, RAM, CHRYSLER WRANGLER, CHEROKEE, GRAND CHEROKEE, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E033000·2018-05-17

    LuK Hybrid Propulsion System Recall for Fire Risk

    LuK is recalling hybrid propulsion systems where oil accumulation may cause an electrical short and increase fire risk. Dealers will inspect and replace components free of charge.

    Product
    HYBRID PROPULSION SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V322000·2018-05-16

    McNeilus Recalls 2008-2018 Bridgemaster V Mixers Due to Tank Rupture Risk

    McNeilus is recalling 2008-2018 Bridgemaster V concrete mixers because a hydraulic tank may overpressurize and rupture, posing risks of injury and road hazards.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1708-2018·2018-05-16

    Datascope Recalls Adult ECC Pack Due to Seal Separation Risk

    Datascope Corporation is recalling three units of the Adult ECC Pack BEQ-TOP 22300 because seal separation may allow air into the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1461-2018·2018-05-16

    Maya Distribution Recalls Dragon Bali Kratom Powder and Capsules for Salmonella

    Maya Distribution, LLC is recalling Dragon Bali Kratom Powder and Capsules because samples collected by public health officials found the presence of Salmonella.

    Product
    Dragon Bali Kratom Powder: 60g Bottle. Dragon Bali Kratom Capsules in bottles:200 ct 500mg, 80 ct x 500, 40 ct x 500mg and 20 ct x 500 mg pouch.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0735-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Albuterol Inhalation Solution Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Albuterol 0.083% Inhalation Solution due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

    Product
    Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1714-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.

    Product
    BEQ-TOP 22701, Catalog No. 701050790
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1483-2018·2018-05-16

    Draeger Fabius Tiro Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 26 Fabius Tiro anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1716-2018·2018-05-16

    Datascope Recalls Custom Tubing Packs Due to Potential Seal Separation

    Datascope is recalling 22 units of BEQ-TOP 33700 ECC 3/8" PACK custom tubing kits because a seal defect may cause balloon collapse and reduced blood flow.

    Product
    BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
    Category
    Medical Device
    Distribution
    13 states