Customed Recalls
682 recalls on record · September 10, 2014 to April 20, 2016 · Medical Devices
Recalls by year
14
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform patient care procedures such as wound heal
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Laparoscopy Pack, Catalog number 900-474. Used by medical staff to perform patient care procedures such as wound heal
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healin
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to perform patient care procedures such as woun
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as woun
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healin
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform patient care procedures such as wound heal
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patie
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care procedures such as wound hea
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, s
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Liposuction Pack, Catalog #900-3028 Used by medical staff to perform patient care procedures such as wound healing, s
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient care procedures such as wound healing, su
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound heali
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture r
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care procedures such as wound healing, sut
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, su
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, su
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound he
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, sutu
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by medical staff to perform patient c
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedur
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff to perform patient care procedures such as
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, s
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care procedures such as wound healing, su
Hazard: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.