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 Shoulder Pack, catalog #900-2616 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 Extremity PACK, catalog #900-2615 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 Hip & Knee Replacement, catalog #900-2614 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 Arthroscopy Pack, catalog #900-2609 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 Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such
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 OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture remo
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 #900-2516 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 Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture
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 Urology Pack, catalog #900-2510 Used by medical staff to perform patient care procedures such as wound healing, sutur
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 III (4), catalog #900-2492 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 Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to perform patient care procedures such as wo
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 1 (2 & 3), catalog #900-2490 Used by medical staff to perform patient care procedures such as wou
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 and Pack (1)(2), catalog #900-2483 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 Cystoscopy Pack III, catalog #900-2482 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 Arthroscopy Pack, catalog #900-2473 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 Basic Pack 1 (III), catalog #900-2471 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 Extremity Arm Pack, catalog #900-2438 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 Total Hysterectomy, catalog #900-2415 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 Vaginal Procedure Pack, catalog #900-2385 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 General Line Full Body Drape, catalog #900-2262 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 Colorectal Surgical Pack, catalog #900-2259A Used by medical staff to perform patient care procedures suc
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 Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture
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 Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing, suture re
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 Surgical Pack, catalog #900-2224 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 Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound h
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 Lithotomy Pack, catalog #900-2167 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 Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, sutur
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 Knee Arthroscopy Pack, catalog #900-2123 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 Angiography Pack, catalog #900-210 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 Angiography Pack, Catalog number 900-2038. Used by medical staff to perform patient care procedures such as wound hea
Hazard: Customed products are being recalled because of 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.