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.

14151–14175 of 29192

  • SevereFDA (Drugs)·D-0860-2018·2018-06-20

    Acne Shave Shave Cream Recalled for Potential Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Shave Cream due to CGMP deviations that may allow bacterial contamination.

    Product
    Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2213-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL XPP Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 5 boxes of RS 5F DL XPP Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL XPP KIT, Catalog Number 60M183104
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2214-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 104 boxes of RS 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M183481
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2205-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 2 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M132324
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2222-2018·2018-06-20

    BioFlo PICC Nursing Kit Recalled for Unsafe Bacterial Endotoxin Levels

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

    Product
    BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2152-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 350 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2174-2018·2018-06-20

    Philips Brilliance 64 CT System Recalled for Patient Support Head Holder Hazard

    Philips is recalling three Brilliance 64 CT systems because the patient support head holder could contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0854-2018·2018-06-20

    PharMEDium Recalls Hydromorphone Syringes Due to Potency Issues

    PharMEDium Services is recalling 2,800 hydromorphone syringes nationwide because some units were found to be superpotent or subpotent.

    Product
    HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0858-2018·2018-06-20

    FDA Recalls X-Jow Pain Gel Due to Potential Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling X-Jow Pain Gel because CGMP deviations may have allowed bacterial contamination.

    Product
    X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2226-2018·2018-06-20

    Seaberg SAM XT-M Tourniquet Recalled for Potential Buckle Failure

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

    Product
    Part #: SAM XT-M, Model: Tactical Black or Military
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2189-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling 50 boxes of Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2216-2018·2018-06-20

    Angiodynamics Recalls RS TANDEM 5F DL BIOFLO PICC Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 15 boxes of RS TANDEM 5F DL BIOFLO PICC kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2221-2018·2018-06-20

    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 (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2211-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 11 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M181578
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2151-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 55 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2208-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 7 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M150373
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Food)·F-1555-2018·2018-06-20

    Hill Country Fare Neapolitan Ice Cream Recalled for Metal Pieces

    H-E-B is recalling Hill Country Fare Neapolitan ice cream in Texas and Mexico because it may contain broken metal pieces.

    Product
    Hill Country Fare Neopolitan 4.5 quarts and 56 ounces; Hill Country Fare Neopolitan (Mexico) 4.5 quarts
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2227-2018·2018-06-20

    Seaberg SAM XT-C Tourniquet Recall Due to Potential Buckle Failure

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

    Product
    Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
    Category
    Medical Device
    Distribution
    23 states