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.

24351–24375 of 32189

  • SevereFDA (Devices)·Z-0364-2015·2014-12-10

    Customed Orthopedic Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 300 Orthopedic Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0326-2015·2014-12-10

    Customed Angiography Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 212 Angiography Packs (Catalog 900-2038) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, Catalog number 900-2038. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0351-2015·2014-12-10

    Customed Gown Cool Impervious XLGE Breathable Recalled for Sterility Compromise

    Customed, Inc. is recalling 144 units of Gown Cool Impervious XLGE Breathable gowns due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0378-2015·2014-12-10

    Customed Major Lap Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 1,680 Major Lap Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0320-2015·2014-12-10

    Customed Universal Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 45 Universal Packs (Catalog 900-1936) because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Universal Pack, Catalog number 900-1936. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0253-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 4,710 surgical gowns because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0602-2015·2014-12-10

    Oasis Brands Recalls Lacteos Santa Martha Queso Fresco Due to Listeria

    Oasis Brands is voluntarily recalling Lacteos Santa Martha Queso Fresco because Listeria monocytogenes was found in environmental and product samples.

    Product
    Queso Fresco (Fresh Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Fresco Fresh Cheese Net Wt 12oz (340g)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0317-2015·2014-12-10

    Customed Arthroscopy Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 12 Arthroscopy Packs (Catalog 900-1832) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0299-2015·2014-12-10

    Customed Urology Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 284 Urology Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Urology Pack, Catalog number 900-1521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0294-2015·2014-12-10

    Customed ENT Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 140 ENT Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0399-2015·2014-12-10

    Customed Recalls Carpal Tunnel Surgical Packs Due to Sterility Compromise

    Customed, Inc. is recalling 660 Carpal Tunnel Surgical Large Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0400-2015·2014-12-10

    Customed Neuro Pack Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 36 Neuro Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0390-2015·2014-12-10

    Customed Laparoscopy Gyn Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 160 Laparoscopy Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0386-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 126 Laparoscopy Packs (Catalog 900-486) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0344-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 400 units of Laparotomy Pack 1 (2 & 3) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0337-2015·2014-12-10

    Customed Vaginal Procedure Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling Vaginal Procedure Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Vaginal Procedure Pack, catalog #900-2385 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0287-2015·2014-12-10

    Customed Pediatric Lap Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 56 Pediatric Lap Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0302-2015·2014-12-10

    Customed Retina Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 84 Retina Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Retina Pack, Catalog number 900-1611. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0283-2015·2014-12-10

    Customed Premium Cesarean Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 150 Premium Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0362-2015·2014-12-10

    Customed Laparotomy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 852 Laparotomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0369-2015·2014-12-10

    Customed Tummy Tuck Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 18 Tummy Tuck Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0359-2015·2014-12-10

    Customed Debridement Tray Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 50 Debridement Trays (Catalog #900-2702) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0244-2015·2014-12-10

    Customed Urethral Catheter Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling Urethral Catheter Trays due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0271-2015·2014-12-10

    Customed Arthroscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 180 Arthroscopy Packs (Catalog 900-1042) because manufacturing and storage deficiencies compromised sterility, posing a risk of patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states