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.

14876–14900 of 29202

  • SevereFDA (Drugs)·D-0323-2018·2018-02-14

    FDA Recalls Sufentanil Citrate Preparations Due to Sterility Concerns

    The FDA is recalling sterile drug preparations made from Sufentanil Citrate Base Solution due to a lack of sterility assurance. The products were compounded by Intrathecal Compounding Specialists.

    Product
    All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0556-2018·2018-02-14

    Recall of Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0561-2018·2018-02-14

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0320-2018·2018-02-14

    FDA Recalls Fentanyl Citrate Sterile Drug Preparations for Sterility Concerns

    Intrathecal Compounding Specialist, LLC is recalling sterile drug preparations made from Fentanyl Citrate Base Solution due to a lack of sterility assurance.

    Product
    All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2018·2018-02-14

    Flawless Beauty Recalls Unapproved Saluta Glutathione Whitening Kits Nationwide

    Flawless Beauty LLC is voluntarily recalling all lots of Saluta Glutathione Whitening kits nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V104000·2018-02-12

    Ford Recalls 2018 Escape and Lincoln MKC for Brake Hose Defect

    Ford is recalling 2018 Escape and Lincoln MKC vehicles because incorrect front brake hoses may chafe and leak fluid, increasing stopping distance.

    Product
    LINCOLN — LINCOLN, FORD MKC, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18096·2018-02-08

    Fujitsu Recalls Notebook Computer Battery Packs Due to Fire and Burn Hazards

    Fujitsu is recalling specific lithium-ion battery packs for notebook computers and workstations because they can overheat, posing fire and burn risks.

    Product
    Battery packs used in Fujitsu notebook computers and workstations.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V101000·2018-02-08

    Micro Bird Recalls T-Series Transit Buses Due to Seat Belt Anchor Defect

    Micro Bird is recalling 2015-2018 T-Series transit buses because seat belt attachments may not remain secured to the floor in a crash, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0267-2018·2018-02-07

    Medline Incision and Drainage Tray Kit Recalled for Subpotent Iodine

    Medline is recalling Incision and Drainage Tray Kits because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0306-2018·2018-02-07

    Medline Anesthesia Kit Recalled for Subpotent Povidone-Iodine Concentration

    Medline Industries is recalling 60 cases of Anesthesia Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2018·2018-02-07

    Medline Recalls Suture Removal Kits with Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the label claim.

    Product
    Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0572-2018·2018-02-07

    FDA Recalls Unapproved Tiger King Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Tiger King tablets because they contain sildenafil, an unapproved drug for erectile dysfunction, and lack FDA approval.

    Product
    Tiger King tablets, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0299-2018·2018-02-07

    Medline Recalls IV Start Kits With Subpotent Iodine Concentration

    Medline Industries is recalling IV Start Kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2018·2018-02-07

    Medline Incision and Drainage Tray Kits Recalled for Subpotent Iodine

    Medline Industries is recalling sterile incision and drainage tray kits because the povidone-iodine prep pads contain less iodine than labeled.

    Product
    Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0566-2018·2018-02-07

    Unapproved herbal capsules containing sildenafil recalled by FDA

    A&H Focal Inc. is recalling HU HU SHENG WEI capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0270-2018·2018-02-07

    Medline Wound Closure Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 80 cases of Wound Closure Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.

    Product
    Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0298-2018·2018-02-07

    Medline Recalls IV Start Kits With Subpotent Iodine Concentration

    Medline Industries is recalling IV Start Kits because the iodine concentration in the prep pads is below the labeled claim of 0.85%.

    Product
    Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0562-2018·2018-02-07

    Unapproved Sildenafil Tablets Recalled by FDA for Lack of Safety Data

    The FDA is recalling ZHANSHENG WEIGE CHAOYUE XILISHI tablets because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0268-2018·2018-02-07

    Medline I&D Tray Kits Recalled for Subpotent Povidone-Iodine Concentration

    Medline Industries is recalling I&D Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2018·2018-02-07

    Medline Recalls Povidone-Iodine Prep Pads Due to Subpotent Iodine Levels

    Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.

    Product
    Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2018·2018-02-07

    Medline Circumcision Tray Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Circumcision Tray Kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0569-2018·2018-02-07

    FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets

    A&H Focal Inc. is recalling DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0261-2018·2018-02-07

    Medline CNTRL Line Removal Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling CNTRL Line Removal Kit Scripps because the iodine content is below the label claim.

    Product
    Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide