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.

176–200 of 682

  • HighFDA (Devices)·Z-2574-2015·2015-09-09

    Customed Laminectomy Pack Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling Laminectomy Pack 3/C units in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2591-2015·2015-09-09

    Customed Foley Catheter Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 160 units of Foley Catheter Kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2672-2015·2015-09-09

    Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 507 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2643-2015·2015-09-09

    Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling surgical gowns in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2670-2015·2015-09-09

    Customed Basic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 77 units of Basic Packs Without Gown due to inadequate validation of sterilization processes and package integrity.

    Product
    BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2648-2015·2015-09-09

    Customed Shoulder Packs Recalled Due to Sterilization Validation Issues

    Customed, Inc. is recalling 413 units of Shoulder Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2687-2015·2015-09-09

    Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Pery-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    PERY-GYN SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2599-2015·2015-09-09

    Customed Laparoscopic Cholecystectomy Kits Recalled for Sterilization Defects

    Customed, Inc. is recalling 120 units of laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.

    Product
    LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2635-2015·2015-09-09

    Customed sterile medical products recalled due to sterilization validation issues

    Customed, Inc. is recalling sterile medical products used for surgical and patient care procedures in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    (1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2585-2015·2015-09-09

    Customed Urology Packs Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 130 packs of Urology Customed Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UROLOGY CUSTOMED PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2700-2015·2015-09-09

    Customed Ortho-Implant Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 639 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2650-2015·2015-09-09

    Customed Face Pack Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 24 units of Face Pack MRT due to inadequate validation of sterilization processes and package integrity.

    Product
    FACE PACK MRT 8/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2627-2015·2015-09-09

    Customed Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 540 surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2626-2015·2015-09-09

    Customed Shoulder Arthroscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 327 units of Shoulder Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2588-2015·2015-09-09

    Customed Angiography Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 130 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ANGIOGRAPHY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2705-2015·2015-09-09

    Customed Femoral Angiography Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 244 units of Femoral Angiography Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    FEMORAL ANGIOGRAPHY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2549-2015·2015-09-09

    Customed Suture Removal Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 20,200 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2618-2015·2015-09-09

    Customed Angiography Kits Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 388 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ANGIOGRAPHY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2717-2015·2015-09-09

    Customed C-Section Kits Recalled for Sterilization Validation Defects

    Customed, Inc. is recalling 92 C-Section Kits due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.

    Product
    C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2593-2015·2015-09-09

    Customed Dressing Change Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,050 units of Dressing Change kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2576-2015·2015-09-09

    Customed Premium Laparotomy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 508 packs of Premium Laparotomy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2604-2015·2015-09-09

    Customed O.B. Packs Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 132 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2621-2015·2015-09-09

    Customed Gauze Recalled Due to Sterilization Validation Deficiencies

    Customed, Inc. is recalling 2-inch by 2-inch gauze pads because of inadequate validation of sterilization processes and package integrity.

    Product
    GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2638-2015·2015-09-09

    Customed Minor Pack Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 1,452 units of Minor Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    MINOR PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2583-2015·2015-09-09

    Customed Umbilical Vessel Catheter Kits Recalled for Sterilization Defects

    Customed, Inc. is recalling 48 umbilical vessel catheter kits due to inadequate validation of sterilization processes and package integrity.

    Product
    UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state