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.

14326–14350 of 29192

  • SevereFDA (Food)·F-1426-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Naturally Kratom White Maeng Da capsules due to potential Salmonella contamination.

    Product
    Naturally Kratom White Maeng Da in 6 capsule bags. 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-0797-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Tasigna Capsules Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Tasigna Capsules 150 mg due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.

    Product
    Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-1435-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Live Well Kratom Red Maeng Da capsules in 150 and 300-count bottles due to potential Salmonella contamination.

    Product
    Live Well Kratom Red Maeng Da 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 (Devices)·Z-1707-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling the Better Bladder device in some custom tubing kits because seal separation may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1713-2018·2018-05-16

    Datascope Recalls Better Bladder Device in Custom Tubing Kits

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

    Product
    BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1718-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 10 custom tubing kits because a seal defect may allow air to enter the housing, causing the balloon to collapse and reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1414-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

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

    Product
    Raw Form Organics Maeng Da Kratom Ivory White; 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 (Devices)·Z-1484-2018·2018-05-16

    Draeger Fabius Tiro M Anesthesia Machine Recalled for Ventilator Failure Risk

    Draeger Medical is recalling one Fabius Tiro M anesthesia machine because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro M, anesthesia machine, catalog no. 8608400 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 mounted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1431-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Products Due to Salmonella Contamination Risk

    Triangle Pharmanaturals LLC is recalling Lifted Kratom Red Maeng Da products due to potential Salmonella contamination. The recall covers powder and capsule bottles distributed across multiple states.

    Product
    Lifted Kratom Red Maeng Da in 45 gram powder, 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-1433-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Products Due to Salmonella Contamination Risk

    Triangle Pharmanaturals LLC is recalling Lifted Kratom Gold Bali products because they may be contaminated with Salmonella.

    Product
    Lifted Kratom Gold Bali in 45 gram powder, 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-1401-2018·2018-05-16

    FDA Recalls Energique Herbal Supplements for Unapproved Drug Claims

    Grato Holdings is recalling Energique herbal supplements because they are marketed as unapproved new drugs based on disease claims.

    Product
    Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1436-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Third Eye Kratom White capsules because all Kratom products from the company may be contaminated with Salmonella.

    Product
    Third Eye Kratom White in 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 (Devices)·Z-1730-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0731-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Due to Sterility Concerns

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

    Product
    Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1472-2018·2018-05-16

    Greenbelt Sunflower Microgreens Recalled for Listeria Contamination Risk

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

    Product
    Sunflower Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00030 8
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1733-2018·2018-05-16

    Datascope recalls custom pediatric ECMO tubing kits due to seal defect

    Datascope is recalling two custom pediatric ECMO tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow.

    Product
    BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1711-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope is recalling Better Bladder devices in custom tubing kits because seal separation may cause balloon collapse and reduced ECMO blood flow.

    Product
    BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1723-2018·2018-05-16

    Datascope Recalls Better Bladder Custom Tubing Kits Due to Seal Separation

    Datascope Corporation is recalling 10 units of the BEQ-T 25501 Better Bladder Pack, Custom Tubing Kit. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0801-2018·2018-05-16

    Coast Quality Pharmacy Recalls MAA Kits Due to Sterility Concerns

    Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits due to a lack of assurance of sterility. The affected products were distributed to six states.

    Product
    Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1623-2018·2018-05-16

    Boston Scientific Recalls Posterior LITE Sutures Due to Breakage Risk

    Boston Scientific Corporation is recalling 1,541 units of the Posterior LITE w/ Capio SLIM device because the sutures may break or detach.

    Product
    Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1390-2018·2018-05-16

    Superior Foods Recalls Smoked Salmon Spread Due to Listeria Risk

    Superior Foods Company is voluntarily recalling specific lots of Smoked Salmon Spread produced on March 26, 2018, due to potential contamination with Listeria monocytogenes.

    Product
    Smoked Salmon Spread 5 lb. bulk units; Simply Superior Smoked Salmon Spread 5 oz units; and Morey s Smoked Salmon Spread 6 oz units; Deli Cups, Deli Tubs
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1469-2018·2018-05-16

    Greenbelt Microgreens Recalled for Potential Listeria Contamination

    Greenbelt Greenhouse Ltd is recalling Sweet & Crunchy Microgreen Mix due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Sweet & Crunchy Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00006 3
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0792-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Bendeka Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling Bendeka 25 mg/mL 4 mL MDVPF due to a lack of processing controls. The affected product was dispensed in five states between December 2017 and February 2018.

    Product
    Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
    Category
    Drug
    Distribution
    5 states