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.

25101–25125 of 32194

  • SevereFDA (Devices)·Z-2310-2014·2014-09-10

    Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Universal Packs containing surgical items due to potential packaging integrity issues that could compromise sterility.

    Product
    Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 93 units of Laparotomy Packs (900-2516) because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2443-2014·2014-09-10

    Customed Recalls Neuro Packs Due to Potential Packaging Integrity Compromise

    Customed, Inc. is recalling Neuro Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2417-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2497-2014·2014-09-10

    Customed Recalls Debridement Trays Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling specific lots of Debridement Trays (code 900-2702) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V541000·2014-09-09

    GM Recalls 2013-2015 Cadillac XTS and Chevrolet Impala for Brake Fire Risk

    General Motors is recalling 2013-2015 Cadillac XTS and 2014-2015 Chevrolet Impala vehicles because the electronic parking brake may not fully retract, potentially causing a fire.

    Product
    CHEVROLET — CHEVROLET, CADILLAC IMPALA, XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V543000·2014-09-09

    GM Recalls 2014 Chevrolet Sonic Vehicles for Air Bag Defect

    General Motors is recalling 2014 Chevrolet Sonic vehicles because a steering column electrical issue may limit air bag deployment in severe crashes.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V542000·2014-09-09

    GM Recalls 2004-2007 Cadillac CTS-V and STS-V for Fuel Pump Fire Risk

    General Motors is recalling specific 2004-2007 Cadillac CTS-V and STS-V vehicles because fuel pump terminals may overheat, melt, and leak fuel, increasing the risk of stalling or fire.

    Product
    CADILLAC — CADILLAC CTS, STS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V540000·2014-09-09

    GM Recalls 2008-2013 Vehicles for Ignition Key Knee Interference Risk

    General Motors is recalling 2008-2009 Pontiac G8 and 2011-2013 Chevrolet Caprice vehicles because the driver's knee may accidentally knock the ignition key out of the run position, potentially disabling safety systems.

    Product
    PONTIAC — PONTIAC, CHEVROLET G8, CAPRICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E060000·2014-09-09

    Clean Fuel USA Recalls LPI Fuel Rails for Propane Leak Risk

    Clean Fuel USA is recalling specific LPI fuel rails for 6 and 8-liter engines because improperly secured injectors or leaking tubes may cause a propane leak, leading to stalling or fire.

    Product
    FUEL SYSTEM, OTHER:DELIVERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V536000·2014-09-05

    Harley-Davidson Recalls 2015 XG500 and XG750 Motorcycles for Fuel Leak Risk

    Harley-Davidson is recalling 2015 XG500 and XG750 motorcycles because the fuel tank filler neck may not seal properly, creating a risk of fuel leaks and vehicle fire.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XG750, XG500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V538000·2014-09-04

    Jet Company Recalls 2014 Side Dump Trailers Due to Suspension Bolt Failure

    Jet Company is recalling 84 model year 2014 Side Dump Trailers because suspension pivot bolts may fail, potentially causing the axle to separate and increasing crash risk.

    Product
    JET COMPANY — JET COMPANY SIDE DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2403-2014·2014-09-03

    Regeneca Recalls RegeneSlim Appetite Control Due to DMAA Presence

    Regeneca, Inc. is recalling RegeneSlim Appetite Control dietary supplements because FDA analysis found the product contains DMAA.

    Product
    RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2243-2014·2014-09-03

    Cook CloverSnare 4-Loop Vascular Retrieval Snare Recalled for Tip Separation

    Cook Inc. is recalling CloverSnare 4-Loop Vascular Retrieval Snares because the snare may separate from the distal tip of the wire.

    Product
    CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign…
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-2395-2014·2014-09-03

    Health Matters America Recalls Organic Traditions Chia Seeds for Salmonella Risk

    Health Matters America Inc. is voluntarily recalling Organic Traditions chia seed products due to possible Salmonella contamination.

    Product
    ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb., UPC 854260006131, UPC 854260006148, no UPC for 50 lb.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-2389-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder potentially contaminated with Salmonella.

    Product
    Tiny Isle Chocolate Truffles Hawaiian Sea Salt: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1564-2014·2014-09-03

    Abrams Royal Pharmacy Recalls All Unexpired Sterile Drug Products

    Abrams Royal Pharmacy is recalling all unexpired sterile drug products due to a lack of assurance of sterility. The products were distributed nationwide and to Canada.

    Product
    All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2380-2014·2014-09-03

    Tiny Isle Original Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Original Fudge is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Original Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil. agave nectar, carob powder, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V523000·2014-09-03

    Collins and Mid Bus School Buses Recalled for Body Joint Adhesive Defect

    NHTSA is recalling 281 model year 2014 Collins and Mid Bus school buses because inadequate adhesive on interior side panel joints may fail to meet federal safety standards.

    Product
    COLLINS — COLLINS, MID BUS DE416WR, DH416, SL408, DE516WR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2402-2014·2014-09-03

    Honey Heaven Wholesale Recalls Organic Raw Carob Powder for Salmonella Risk

    Honey Heaven Wholesale is recalling Organic Raw Carob Powder due to potential Salmonella contamination. The product was distributed to processors and retail outlets in Oregon, Washington, and California.

    Product
    Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-packaged and sold in five pound plastic bags. Five pound bags are labeled in part "OG RAW CAROB POWDER*** C110-5# Lot: *** 5 lbs***Distributed by Hummingbird Wholesale Eugene, OR 97401…
    Category
    Food
    Distribution
    3 states