The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

10151–10175 of 29157

  • SevereFDA (Devices)·Z-1025-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1011-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1003-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1035-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0826-2020·2020-02-12

    PD-Rx Recalls Ranitidine Hydrochloride Tablets Due to NDMA Contamination

    PD-Rx Pharmaceuticals is recalling specific lots of ranitidine hydrochloride 150 mg tablets because a supplier reported potential NDMA levels above established limits.

    Product
    ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-
    Category
    Drug
    Distribution
    12 states
  • SevereFDA (Food)·F-0637-2020·2020-02-12

    Golden State Foods Recalls Taco Bell Creamy Jalapeno Sauce Due to Metal Fragments

    Golden State Foods is recalling Taco Bell Creamy Jalapeno Sauce because a starch ingredient used in its manufacture contained metal fragments.

    Product
    Taco Bell Creamy Jalapeno Sauce; GIN: 54973 12/25.5 oz. Pouches Net Wt: 19.12 lbs.(8.68 kg) Supplier ID: 0005320-01 GSF Product # 02598 Customer Product #: 0054943 Packed exclusively for use by Taco Bell and its franchisees. Taco Bell Corp., Irvine, CA 92618
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0976-2020·2020-02-12

    Cook Inc. Recalls Sof-Flex Ureteral Stent Sets Due to Loading Error

    Cook Inc. is recalling 13,388 Sof-Flex Multi-Length Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient.

    Product
    Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0980-2020·2020-02-12

    Pacific Medical Fetal Transducers Recalled for Lack of Regulatory Clearance

    Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.

    Product
    Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-1008-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V076000·2020-02-12

    Audi TT Recall: Fuel Tank Heat Shield Bracket Fire Risk

    Volkswagen is recalling 2016-2019 Audi TT vehicles because a fuel tank heat shield bracket may damage the tank in a crash, causing a fuel leak and fire risk.

    Product
    AUDI — AUDI TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0614-2020·2020-02-12

    Almark Foods Recalls Free Range Hard-Cooked Hen Eggs Due to Listeria Risk

    Almark Foods, LLC is recalling free range hard-cooked hen eggs sold under the Farmer's Hen House and Nellie's brands due to a potential Listeria monocytogenes genetic match between facility samples and illness outbreak cases.

    Product
    Free Range Hard-Cooked Hen Eggs sold under the brand names of Farmer's Hen House and Nellie's
    Category
    Food
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1024-2020·2020-02-12

    Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling RoyalSilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0581-2020·2020-02-12

    Daniel Boulud Smoked Salmon Recalled for Listeria Contamination Risk

    CATSMO LLC is recalling Daniel Boulud brand Baja flavored smoked salmon due to potential Listeria monocytogenes contamination.

    Product
    Daniel Boulud brand Baja flavored (8oz) smoked salmon products manufactured on 11/19/19 by Catsmo Acquisition LLC packaged in vacuum pouches.
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0927-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci SP Systems Due to Defective Capacitors

    Intuitive Surgical is recalling four da Vinci SP Surgical Systems because defective capacitors on circuit boards may cause vision loss or non-recoverable system errors.

    Product
    da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0673-2020·2020-02-12

    Lipari Foods Recalls Premo Bologna Sandwiches Due to Listeria Risk

    Lipari Foods is recalling Premo Bologna & Cheese Wedge Sandwiches due to potential contamination with Listeria monocytogenes. The products were distributed to food service and retail stores in 15 states.

    Product
    Premo Bologna & Cheese Wedge Sandwich 5 oz., UPC: 612510093306
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0825-2020·2020-02-12

    Spectrum Chemical Recalls Ranitidine Hydrochloride Powder Due to NDMA Impurity

    Spectrum Laboratory Products is recalling Ranitidine Hydrochloride powder due to the presence of NDMA impurity. The product was distributed to pharmacies in 11 US states and internationally.

    Product
    Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
    Category
    Drug
    Distribution
    11 states
  • SevereNHTSA·20V074000·2020-02-11

    Blue Bird Recalls 2018-2019 School Buses Due to Wire Harness Defect

    Blue Bird is recalling 2018-2019 Vision and All American school buses because a wire harness connector may unplug, causing sudden loss of drive power and power steering.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V070000·2020-02-10

    Forest River Recalls 2020 Cedar Creek Trailers Due to Fire Risk

    Forest River is recalling 2020 Cedar Creek trailers because the stove may be too close to the window valance, posing a fire hazard.

    Product
    FOREST RIVER — FOREST RIVER CEDAR CREEK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V071000·2020-02-10

    Yamaha Recalls 2019 YZF-R3 Motorcycles Due to Front Brake Hose Chafing

    Yamaha is recalling 1,561 2019 YZF-R3 motorcycles because the front brake hose may chafe against the horn wire, potentially causing a brake fluid leak and reduced braking ability.

    Product
    YAMAHA — YAMAHA YZFR3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·006-2020·2020-02-08

    Family Traditions Recalls Beef Sticks for Undeclared Milk Allergen

    Family Traditions Meat Company is recalling ready-to-eat beef sticks because they contain milk, an undeclared allergen. No illnesses have been reported.

    Product
    Family Traditions Meat Company, Inc. — Family Traditions Meat Company Recalls Ready-to-Eat Meat Stick Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·20V066000·2020-02-06

    Honda Recalls 2018-2020 Odyssey Vehicles for Electrical Fire Risk

    Honda is recalling 2018-2020 Odyssey vehicles because a pinched wire harness in the third row seat area could cause an electrical short and fire.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0574-2020·2020-02-05

    Jeni's Dairy Free Cold Brew Pints Recalled for Undeclared Milk Allergen

    Jeni's Splendid Ice Creams LLC is recalling 49,358 pints of Dairy Free Cold Brew with Coconut Cream frozen dessert because they may contain undeclared milk.

    Product
    Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen dessert
    Category
    Food
    Distribution
    50 states