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.

251–275 of 682

  • HighFDA (Devices)·Z-2568-2015·2015-09-09

    Customed Neuro Pack 3/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 15 packs of NEURO PACK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    NEURO 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-2590-2015·2015-09-09

    Customed Laparotomy Kits Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 1,072 units of Laparotomy Kits due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROTOMY 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-2679-2015·2015-09-09

    Customed Minor Laparotomy Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 675 Minor Laparotomy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    MINOR LAPAROTOMY 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-2683-2015·2015-09-09

    Customed Polyreinforced Surgical Gowns Recalled for Sterilization Validation Issues

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

    Product
    GOWN POLYREINF XLGE TOWEL/W 24/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-2598-2015·2015-09-09

    Customed Femoral Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 320 units of Femoral Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    FEMORAL 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-2571-2015·2015-09-09

    Customed Laparoscopic OB GYN Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 95 packs of laparoscopic OB GYN kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSC. OB GYN 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-2691-2015·2015-09-09

    Customed Angiography Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 370 units of Angiography Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ANGIOGRAPHY 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-2603-2015·2015-09-09

    Customed Recalls Peri Gyn Packs Due to Sterilization Validation Issues

    Customed, Inc. is recalling 80 units of Peri Gyn Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.

    Product
    PERI GYN PACK 10/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-2652-2015·2015-09-09

    Customed Shoulder Arthroscopy Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 10 units of Shoulder Arthroscopy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER ARTHROSCOPY PACK 2/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-2666-2015·2015-09-09

    Customed Face Packs Recalled Due to Sterilization Validation Issues

    Customed, Inc. is recalling 16 units of Face Packs in Puerto Rico because the sterilization process and package integrity were not adequately validated.

    Product
    FACE PACK FJG 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
  • HighFDA (Devices)·Z-2699-2015·2015-09-09

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY SURGICAL PACK 4/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-2637-2015·2015-09-09

    Customed Urology Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 450 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UROLOGY 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-2698-2015·2015-09-09

    Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN 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-2714-2015·2015-09-09

    Customed Arthroscopy PK L/F 5/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY PK L/F 5/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-2580-2015·2015-09-09

    Customed Recalls Pediatric Lap Packs Due to Sterilization Validation Issues

    Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.

    Product
    PEDIATRIC LAP PACK 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
  • ModerateFDA (Devices)·Z-2642-2015·2015-09-09

    Customed Surgical Gowns Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling surgical gowns 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
  • ModerateFDA (Devices)·Z-2667-2015·2015-09-09

    Customed Laparoscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY PACK 2/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
  • ModerateFDA (Devices)·Z-2609-2015·2015-09-09

    Customed Minor Laceration Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.

    Product
    MINOR LACERATION TRAY 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
  • ModerateFDA (Devices)·Z-2663-2015·2015-09-09

    Customed Breast Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 24 units of Breast Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    BREAST PACK-BOD 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
  • ModerateFDA (Devices)·Z-2553-2015·2015-09-09

    Customed Universal Drainage Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 960 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UNIVERSAL DRAINAGE TRAY CUSTOMED 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
  • CriticalFDA (Devices)·Z-0296-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0311-2015·2014-12-10

    Customed Minor Laparotomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 625 Minor Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0383-2015·2014-12-10

    Customed Minor Laparotomy Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Minor Laparotomy Pack, Catalog number 900-450. 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-0358-2015·2014-12-10

    Customed Tummy Tuck and Liposuction Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling six Tummy Tuck & Liposuction Packs due to compromised sterility and manufacturing deficiencies that pose a risk of patient infection.

    Product
    Tummy Tuck & Liposuction Pack, catalog #900-2661 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-0408-2015·2014-12-10

    Customed Plastic Surgery Pack Recalled for Sterility Compromise

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

    Product
    Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states