The Recall Desk

Manufacturer

Customed, Inc

682 recalls in our database name Customed, Inc as the manufacturing or recalling firm.

What the numbers show

Total
682
Critical
29
Severe
398
Most recent
2016-04-20

Of the 682 recalls from Customed, Inc we have scored against our rubric, 29 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 398 (58%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

401–425 of 682

  • SevereFDA (Devices)·Z-0319-2015·2014-12-10

    Customed Ophthalmic Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Ophtalmic Pack, Catalog number 900-1933. 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-0392-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 340 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-620. 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-0322-2015·2014-12-10

    Customed Medical Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 160 Higado & Pancrea Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Higado & Pancrea Pack, Catalog number 900-1966. 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-0289-2015·2014-12-10

    Customed Plastic Surgery Packs Recalled for Compromised Sterility

    Customed, Inc. is recalling 40 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Plastic Surgery Pack, Catalog number 900-1402. 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-0370-2015·2014-12-10

    Customed Liposuction Pack Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Liposuction Pack, Catalog #900-3028 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-0306-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 126 Cesarean Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Cesarean Pack, Catalog number 900-1689. 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-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 (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