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.

14126–14150 of 29192

  • SevereUSDA FSIS·055-2018·2018-06-25

    People's Sausage Recalls Jerky and Meat Sticks Produced Without Inspection

    People's Sausage Co. is recalling approximately 13,554 pounds of jerky and meat stick products produced without an approved voluntary grant of inspection.

    Product
    People's Sausage Company, Inc. — People's Sausage Co. Recalls Jerky and Meat Stick Products Produced without an Approved Voluntary Grant of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·053-2018·2018-06-22

    Quay Corporation Recalls Pork Lard Produced Without Federal Inspection

    The Quay Corporation is recalling approximately 258,121 pounds of pork lard products produced without the benefit of federal inspection. The products were shipped to retail locations in Texas.

    Product
    The Quay Corporation — Quay Corporation Recalls Pork Products Produced Without Benefit Of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V427000·2018-06-22

    Audi Recalls A4, A6, and RS4 Models Due to Air Bag Inflator Defect

    Volkswagen Group of America is recalling specific Audi models because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    AUDI — AUDI A4, A6, RS 4, RS4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V422000·2018-06-21

    Triple E RV Recalls 2017-2018 Wonder Models Due to Wiring Defect

    Triple E RV is recalling 2017-2018 Wonder recreational vehicles because water can corrode wiring in the trailer tow module, potentially causing electrical shorts, fire, or crash risks.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2156-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 361 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0864-2018·2018-06-20

    Inopak Recalls Antibacterial Foaming Hand Wash Due to Microbial Contamination

    Inopak Ltd is recalling Option Systems Antibacterial Foaming Hand Wash because FDA analysis found out-of-specification microbial counts.

    Product
    Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2212-2018·2018-06-20

    Angiodynamics Recalls RS Tandem 5F DL Xcela PICC Catheters

    Angiodynamics Inc. is recalling 13 boxes of RS Tandem 5F DL Xcela PICC catheters because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
    Category
    Medical Device
    Distribution
    34 states
  • SevereNHTSA·18E043000·2018-06-20

    TRW Air Bag Control Unit Recall for Hyundai and Kia Vehicles

    TRW is recalling air bag control units in certain Hyundai and Kia vehicles because electrical overstress may prevent air bags and seat belt pretensioners from deploying in a crash.

    Product
    AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2217-2018·2018-06-20

    Angiodynamics Recalls PICC Nursing Trays Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 2 boxes of CAN 5F DL BIOFLO PASV PICC Nursing Trays because a component may contain unsafe levels of bacterial endotoxins.

    Product
    CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2210-2018·2018-06-20

    Angiodynamics Recalls 5F DL BIOFLO PICC Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 5F DL BIOFLO PICC kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    5F DL BIOFLO PICC, Catalog Number 60M180592
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2175-2018·2018-06-20

    Philips Brilliance 16 CT System Recalled for Head Holder Contact Hazard

    Philips is recalling two Brilliance 16 CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Food)·F-1547-2018·2018-06-20

    Pious Lion Kratom Product Recalled Due to Salmonella Contamination

    Pious Lion is recalling 4 oz bags of White Maeng DA Kratom because the North Carolina Department of Agriculture found the product contains Salmonella.

    Product
    Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz plastic bag. 833-AVL-KRTM www.piouslion.com
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2218-2018·2018-06-20

    Angiodynamics Recalls XCELA PICC Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2202-2018·2018-06-20

    Angiodynamics Recalls Bioflo Midline Catheters Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2196-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling 298 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2176-2018·2018-06-20

    Philips Brilliance 16 P CT Systems Recalled for Head Holder Contact Risk

    Philips is recalling 20 Brilliance 16 P CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0861-2018·2018-06-20

    Acne Shave 3 Step Shaving System Recalled for Bacterial Contamination Risk

    Shadow Holdings DBA Bocchi Labs is recalling the Acne Shave 3 Step Shaving System due to CGMP deviations that may result in bacterial contamination.

    Product
    Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0855-2018·2018-06-20

    Medline recalls flushable personal cleaning cloths due to microbial contamination

    Medline Industries is recalling specific lots of READYFLUSH PROTECT flushable personal cleaning cloths because of microbial contamination in a non-sterile product.

    Product
    READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2153-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 113 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0875-2018·2018-06-20

    Allergan Recalls Taytulla Contraceptive Softgels Due to Out-of-Sequence Tablets

    Allergan is recalling Taytulla softgel capsules because the tablets are out of sequence. This affects 168,768 blister cards distributed nationwide.

    Product
    TAYTULLA — TAYTULLA (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2192-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling 17 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2228-2018·2018-06-20

    Seaberg SAM XT-C Tourniquet Recalled for Potential Buckle Stitch Failure

    The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle could fail, posing a risk of serious injury or death.

    Product
    Part #: SAM XT-C, Model: Hi-Viz Blue
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2223-2018·2018-06-20

    Angiodynamics Recalls BioFlo PICC Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033
    Category
    Medical Device
    Distribution
    34 states