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.

14351–14375 of 29192

  • SevereFDA (Devices)·Z-1699-2018·2018-05-16

    Siemens Recalls Syngo.plaza Software to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1728-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope Corporation is recalling BEQ-TOP 22301 Custom Tubing Kits because seal separation may allow air to enter the housing, causing the balloon to collapse and reducing blood flow.

    Product
    BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0732-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns

    Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1706-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling specific custom tubing kits because the Better Bladder device may allow air to enter, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0754-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Azithromycin Tablets Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Azithromycin 250 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

    Product
    Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1731-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling 11 custom tubing kits containing the Better Bladder device due to a seal defect that may cause balloon collapse and reduced blood flow.

    Product
    BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0729-2018·2018-05-16

    Vitalab Alprostadil Injectable Recalled for Sterility Assurance Concerns

    Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL injectable vials because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1739-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

    Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.

    Product
    Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1712-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
    Category
    Medical Device
    Distribution
    13 states
  • SevereNHTSA·18V318000·2018-05-16

    Porsche Recalls 2018 Macan Models Due to Control Unit Failure Risk

    Porsche is recalling 2018 Macan and Macan S vehicles because a control unit may fail, potentially impairing safety functions and drivability.

    Product
    PORSCHE — PORSCHE MACAN, MACAN S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1721-2018·2018-05-16

    Datascope Custom Tubing Kit Recall Due to Seal Separation

    Datascope is recalling 9 custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1715-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may cause balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0730-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drug Due to Sterility Concerns

    Vitalab Pharmacy is recalling 22 vials of a sterile injectable drug because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1725-2018·2018-05-16

    Datascope recalls NICU ECC Pack custom tubing kits due to seal defect

    Datascope is recalling specific NICU ECC Pack custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.

    Product
    NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1720-2018·2018-05-16

    Datascope Recalls Custom Neonatal ECC Tubing Kits Due to Seal Defect

    Datascope is recalling seven custom neonatal ECMO tubing kits because a seal defect may allow air entry, potentially causing a drop in blood flow.

    Product
    BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1666-2018·2018-05-16

    Baxter Infusion Pump Recalled for Improper Testing Documentation

    Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1467-2018·2018-05-16

    Greenbelt Broccoli Microgreens Recalled for Potential Listeria Contamination

    Greenbelt Greenhouse Ltd is recalling 498 packages of Broccoli Microgreens due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Broccoli Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00016 2
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1413-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Raw Form Organics Maeng Da Kratom Emerald Green capsules because they may be contaminated with Salmonella.

    Product
    Raw Form Organics Maeng Da Kratom Emerald Green; 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1416-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Products Due to Salmonella Contamination

    Triangle Pharmanaturals LLC is recalling Raw Form Organics Maeng Da Kratom Amethyst Gold capsules due to potential Salmonella contamination.

    Product
    Raw Form Organics Maeng Da Kratom Amethyst Gold in 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-0791-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Capecitabine Tablets Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Capecitabine 500 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

    Product
    Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1482-2018·2018-05-16

    Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 27 Fabius GS Premium anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1722-2018·2018-05-16

    Datascope Better Bladder Custom Tubing Kit Recalled for Seal Separation

    Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.

    Product
    BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1726-2018·2018-05-16

    Datascope Recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits

    Datascope is recalling four BEQ-TOP 24500 Adult ECC Custom Tubing Kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
    Category
    Medical Device
    Distribution
    13 states