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.

351–375 of 682

  • SevereFDA (Devices)·Z-0394-2015·2014-12-10

    Customed Fanfold Drape Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 6,300 Fanfold Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Fanfold Drape, Catalog number 900-633. 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-0376-2015·2014-12-10

    Customed Basic Pack W/Out Gown Recalled for Sterility Compromise

    Customed, Inc. is recalling 242 units of Basic Pack W/Out Gown due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Basic Pack W/Out Gown, Catalog number 900-345. 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-0333-2015·2014-12-10

    Customed Ear Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 105 Ear Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Ear Pack, catalog #900-2234 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-0339-2015·2014-12-10

    Customed Extremity Arm Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 92 Extremity Arm Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Extremity Arm Pack, catalog #900-2438 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-0264-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 2,670 surgical gowns because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. 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-0282-2015·2014-12-10

    Customed Laminectomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 180 Laminectomy Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Laminectomy Pack, Catalog number 900-1202. 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-0330-2015·2014-12-10

    Customed Lithotomy Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 460 Lithotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Lithotomy Pack, catalog #900-2167 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-0243-2015·2014-12-10

    Customed Suction Catheter Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling Suction Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Suction Catheter Kit, Catalog number 900-277. 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-0298-2015·2014-12-10

    Customed Cardiovascular Case Carts 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 900-1500. 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-0274-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 256 Arthroscopy Packs (Catalog 900-1062) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-1062. 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-0305-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 246 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-1688. 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-0252-2015·2014-12-10

    Customed Wound Management Tray II Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Management Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Management Tray II, Catalog number 900-1198. 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-0300-2015·2014-12-10

    Customed Dressing Change Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling 1,050 Dressing Change kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Dressing Change, Catalog number 900-1538. 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-0332-2015·2014-12-10

    Customed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 880 surgical packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Surgical Pack, catalog #900-2224 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-0391-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 210 Angiography Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Angiography Pack, Catalog number 900-610. 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-0349-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 64 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, catalog #900-2516 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-0257-2015·2014-12-10

    Customed Mayo Stand Covers Recalled for Compromised Sterility

    Customed, Inc. is recalling Mayo Stand Covers with CSR Wrap due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. 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-0329-2015·2014-12-10

    Customed Femoral Pack Recalled Due to Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Femoral Pack, catalog #900-2164 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-0396-2015·2014-12-10

    Customed O.B. Pack Recall Due to Sterility Compromise

    Customed, Inc. is recalling 420 O.B. Packs (Catalog 900-645) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    O.B. Pack, Catalog number 900-645. 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-0261-2015·2014-12-10

    Customed Recalls Surgical Gowns Due to Compromised Sterility

    Customed, Inc. is recalling 2,520 surgical gowns because compromised sterility and inadequate storage conditions may increase the risk of patient infection.

    Product
    Gown Surgical Non Reinforced XXL, Catalog number 900-2566. 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-0275-2015·2014-12-10

    Customed Recalls Peri Gyn Packs Due to Compromised Sterility

    Customed, Inc. is recalling 740 Peri Gyn Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states