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
196
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 196 (29%) 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.

376–400 of 682

  • 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-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-0377-2015·2014-12-10

    Customed Cesarean Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 654 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cesarean Pack, Catalog number 900-403. 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-0237-2015·2014-12-10

    Customed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 185,000 surgical packs distributed in Florida, New York, and Puerto Rico because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Surgical packs (includes trays, bags and kits) 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-0242-2015·2014-12-10

    Customed Tracheotomy Care Kits Recalled for Sterility Compromise

    Customed, Inc. is recalling Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Tracheotomy Care Kit, Catalog number 900-110. 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-0352-2015·2014-12-10

    Customed Arthroscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 75 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Arthroscopy Pack, catalog #900-2609 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-0315-2015·2014-12-10

    Customed Ophthalmic Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 582 Ophthalmic Packs due to compromised sterility and inadequate storage conditions that may result in patient infection.

    Product
    Ophtalmic Pack, Catalog number 900-1780. 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-0389-2015·2014-12-10

    Customed Laparoscopy Cholecystectomy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. 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-0373-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 96 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-3178. 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-0280-2015·2014-12-10

    Customed Laparoscopy OB GYN Packs Recalled for Compromised Sterility

    Customed, Inc. is recalling 105 Laparoscopy OB GYN Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy OB GYN Pack, Catalog number 900-1192. 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-0404-2015·2014-12-10

    Customed Cesarean Pack Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 264 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cesarean Pack, Catalog # 900-851 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-0398-2015·2014-12-10

    Customed Arthroscopy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 400 Arthroscopy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Arthroscopy Surgical Pack, Catalog # 900-740A 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-0385-2015·2014-12-10

    Customed Laparoscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 48 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-484 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-0328-2015·2014-12-10

    Customed Recalls Knee Arthroscopy Packs Due to Sterility Compromise

    Customed, Inc. is recalling 144 Knee Arthroscopy Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    Knee Arthroscopy Pack, catalog #900-2123 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-0387-2015·2014-12-10

    Customed Laparotomy Basic Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 70 Laparotomy Basic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Laparotomy Basic Pack, Catalog number 900-547 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-0414-2015·2014-12-10

    Customed Peri Gyn Pack Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 230 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Peri Gyn Pack, Catalog # 900-997 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-0285-2015·2014-12-10

    Customed Premium OB Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 335 Premium OB Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Premium OB Pack, Catalog number 900-1297. 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-0272-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 480 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-1059. 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-0239-2015·2014-12-10

    Customed Universal Drainage Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Universal Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Universal Drainage Tray, Catalog number 900-032. 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-0303-2015·2014-12-10

    Customed Femoral Pack Recall Due to Compromised Sterility

    Customed, Inc. is recalling 270 Femoral Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Femoral Pack, Catalog number 900-164. 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-0266-2015·2014-12-10

    Customed O.B. Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 176 O.B. Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    O.B. Pack, Catalog number 900-012. 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-0318-2015·2014-12-10

    Customed Recalls Hip Orthopedia Packs Due to Compromised Sterility

    Customed, Inc. is recalling 36 Hip Orthopedia Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states