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
196
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 196 (29%) 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.

226–250 of 682

  • HighFDA (Devices)·Z-2690-2015·2015-09-09

    Customed Laparoscopy GYN PK CS/4 Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 112 units of Laparoscopy GYN PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY GYN PK CS/4 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-2578-2015·2015-09-09

    Customed Premium Arthroscopy PK Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 55 packs of Premium Arthroscopy PK due to inadequate validation of sterilization processes and package integrity.

    Product
    PREMIUM ARTHROSCOPY PK CUSTOMED 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-2665-2015·2015-09-09

    Customed Tummy Tuck Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Tummy Tuck Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    TUMMY TUCK PACK-FJG 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-2570-2015·2015-09-09

    Customed Laparoscopy Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 138 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY 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-2703-2015·2015-09-09

    Customed Skin Staple Remover Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,180 Skin Staple Remover Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SKIN STAPLE REMOVER KIT 80/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-2555-2015·2015-09-09

    Customed Minor Procedure Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 80 Minor Procedure Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    MINOR PROCEDURE PACK 40/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-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-2641-2015·2015-09-09

    Customed O.B. Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 125 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    O.B. 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-2662-2015·2015-09-09

    Customed Hair Restoration Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 18 units of Hair Restoration Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    HAIR RESTORATION PACK-THR 12/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-2653-2015·2015-09-09

    Customed Medical Device Recall for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 210 units of knee and hip replacement devices distributed in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    REEMPLAZO DE RODILLA Y CADERA 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-2647-2015·2015-09-09

    Customed Extremity Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 285 units of Extremity Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    EXTREMITY 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-2550-2015·2015-09-09

    Customed O.B. PK Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 48 packs of O.B. PK surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    O.B. 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-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-2661-2015·2015-09-09

    Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues

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

    Product
    OBSTETRICAL SURGICAL 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-2657-2015·2015-09-09

    Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,866 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROTOMY SURGICAL 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-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-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-2617-2015·2015-09-09

    Customed Shoulder Pack Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 6 units of Shoulder Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER PACK CUSTOMED 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-2682-2015·2015-09-09

    Customed Laparoscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 78 units of Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY 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-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-2619-2015·2015-09-09

    Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 18,000 units of 2"x2" 4-ply sterile gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/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-2685-2015·2015-09-09

    Customed Gauze Sponges Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling sterile gauze sponges due to inadequate validation of sterilization processes and package integrity.

    Product
    GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) 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-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