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.

326–350 of 682

  • SevereFDA (Devices)·Z-0265-2015·2014-12-10

    Customed Angiodrape Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,152 Angiodrape Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiodrape Pack, Catalog number 900-002. 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-0366-2015·2014-12-10

    Customed ACDF Pack Recalled Due to Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling six ACDF Packs (catalog #900-2917) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    ACDF Pack, catalog #900-2917 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-0278-2015·2014-12-10

    Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 132 Neuro Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Neuro Pack, Catalog number 900-1146. 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-0368-2015·2014-12-10

    Customed Hair Restoration Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 60 Hair Restoration Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Hair Restoration Pack, Catalog #900-2966 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-0321-2015·2014-12-10

    Customed Endovenous Custom Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 35 Endovenous Custom Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Endovenous Custom Pack, Catalog number 900-1937. 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-0263-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 2,240 surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. 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-0256-2015·2014-12-10

    Customed Minor Laceration Trays Recalled Due to Compromised Sterility

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

    Product
    Minor Laceration Tray, Catalog number 900-1765. 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-0395-2015·2014-12-10

    Customed Recalls Pery Gyn Packs Due to Sterility Compromise

    Customed, Inc. is recalling 475 Pery Gyn Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    Pery Gyn Pack, Catalog number 900-635. 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-0290-2015·2014-12-10

    Customed Umbilical Vessel Catheter Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling 48 Umbilical Vessel Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Umbilical Vessel Catheter Kit, Catalog number 900-1408. 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-0360-2015·2014-12-10

    Customed Knee and Hip Replacement Trays Recalled for Sterility Compromise

    Customed, Inc. is recalling 160 Knee and Hip Replacement trays due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 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-0334-2015·2014-12-10

    Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 114 Neuro Packs (catalog #900-2256) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Neuro Pack, catalog #900-2256 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-0340-2015·2014-12-10

    Customed Basic Pack 1 (III) Recalled for Sterility Compromise

    Customed, Inc. is recalling 400 units of Basic Pack 1 (III) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Basic Pack 1 (III), catalog #900-2471 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-0406-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 60 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog # 900-902 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-0365-2015·2014-12-10

    Customed Cysto Tur Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 128 Cysto Tur Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cysto Tur Pack, catalog #900-2899 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-0314-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 2,520 Laparotomy Packs (Catalog 900-176) because compromised sterility and inadequate storage increase the risk of patient infection.

    Product
    Laparotomy Pack, Catalog number 900-176. 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-0258-2015·2014-12-10

    Customed Wound Management Tray Recalled for Compromised Sterility

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

    Product
    Wound Management Tray, Catalog number 900-1903. 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-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-0301-2015·2014-12-10

    Customed Universal Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 156 Universal Packs (Catalog 900-1587) because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Universal Pack, Catalog number 900-1587. 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-0403-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, Catalog # 900-848 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-0292-2015·2014-12-10

    Customed Recalls Reyito Urological Packs Due to Compromised Sterility

    Customed, Inc. is recalling 315 Reyito Urological Packs because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Reyito Urological Pack, Catalog number 900-1460. 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-0327-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,068 Angiography Packs due to significant compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, catalog #900-210 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-0249-2015·2014-12-10

    Customed Incision and Drainage Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling 9,200 Incision & Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Incision & Drainage Tray, Catalog number 900-774. 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-0336-2015·2014-12-10

    Customed Full Body Drape Recalled for Sterility Compromise

    Customed, Inc. is recalling 308 units of General Line Full Body Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states