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.

301–325 of 682

  • SevereFDA (Devices)·Z-0338-2015·2014-12-10

    Customed Total Hysterectomy Kits Recalled for Sterility Compromise

    Customed, Inc. is recalling six Total Hysterectomy kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Total Hysterectomy, catalog #900-2415 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-0384-2015·2014-12-10

    Customed Laparoscopy Packs Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 240 Laparoscopy Packs (Catalog 900-474) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-474. 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-0313-2015·2014-12-10

    Customed Urology Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 60 Urology Packs (Catalog 900-1742) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Urology Pack, Catalog number 900-1742. 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-0307-2015·2014-12-10

    Customed Open Heart Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 160 Open Heart Trays (Catalog 900-170) due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Open Heart Tray, Catalog number 900-170. 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-0273-2015·2014-12-10

    Customed Peri Gyn Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 162 units of Peri Gyn Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Peri Gyn Pack, Catalog number 900-1061. 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-0308-2015·2014-12-10

    Customed Peri Gyn Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 180 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Peri Gyn Pack, Catalog number 900-1716. 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-0297-2015·2014-12-10

    Customed D&C Laparoscopy Packs Recalled for Compromised Sterility

    Customed, Inc. is recalling 176 D&C Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    D&C Laparoscopy Pack, Catalog number 900-1496. 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-0312-2015·2014-12-10

    Customed Urology Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 40 Urology Packs (Catalog 900-1738) due to compromised sterility and inadequate storage conditions that may result in patient infection.

    Product
    Urology Pack, Catalog number 900-1738. 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-0335-2015·2014-12-10

    Customed Laparoscopy Colorectal Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Colorectal Surgical Pack, catalog #900-2259A 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-0402-2015·2014-12-10

    Customed Femoral Angiography Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 236 units of Femoral Angiography Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Femoral Angiography Pack, Catalog number 900-796. 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-0240-2015·2014-12-10

    Customed Wound Closure Tray I Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Wound Closure Tray I units because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Wound Closure Tray I, Catalog number 900-063. 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-0259-2015·2014-12-10

    Customed Gown Surg Fully Impervious Large Recalled for Compromised Sterility

    Customed, Inc. is recalling 170 units of Gown Surg Fully Impervious Large due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surg Fully Impervious Large, Catalog number 900-2564. 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-0267-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 1,152 Laparoscopy Packs (Catalog 900-028) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-028. 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-0325-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 36 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-2004. 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-0405-2015·2014-12-10

    Customed Urology Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 195 Urology Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Urology Pack, Catalog # 900-868 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-0291-2015·2014-12-10

    Customed Cardiovascular Case Cart Recalled for Compromised Sterility

    Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. 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-0346-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 400 Laparotomy Pack III units due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack III (4), catalog #900-2492 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-0288-2015·2014-12-10

    Customed Open Heart Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 108 Open Heart Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Open Heart Tray, Catalog number 900-1393. 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-0393-2015·2014-12-10

    Customed Recalls O.R. Towels Due to Sterility Compromise

    Customed, Inc. is recalling 550 O.R. Towels (Catalog 900-629) because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    O.R. Towels, Catalog number 900-629. 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-0343-2015·2014-12-10

    Customed Laparoscopy and Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 240 units of Laparoscopy and Pack (catalog #900-2483) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy and Pack (1)(2), catalog #900-2483 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-0324-2015·2014-12-10

    Customed Orthopedic Trays Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 36 orthopedic trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Orthopedic tray, Catalog number 900-1985 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-0341-2015·2014-12-10

    Customed Arthroscopy Pack Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 200 Arthroscopy Packs (catalog #900-2473) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Arthroscopy Pack, catalog #900-2473 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