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.

276–300 of 682

  • SevereFDA (Devices)·Z-0348-2015·2014-12-10

    Customed Minor Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 944 Minor Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Minor Pack, catalog #900-2511 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-0255-2015·2014-12-10

    Customed Medical Leggings Recalled Due to Compromised Sterility

    Customed, Inc. is recalling medical leggings used for patient care procedures because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Leggings W/7'' Cuff, Catalog number 900-1574. 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-0382-2015·2014-12-10

    Customed Cysto Tur Pack Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 75 units of Cysto Tur Pack (Catalog 900-430) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cysto Tur Pack, Catalog number 900-430 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-0372-2015·2014-12-10

    Customed Face Lift Recall Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 20 units of Face Lift products (Catalog 900-3083) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Face Lift, Catalog number 900-3083. 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-0407-2015·2014-12-10

    Customed Medical Kits Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 100 units of medical kits (Catalog # 900-913) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    , Catalog # 900-913 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-0375-2015·2014-12-10

    Customed Breat Pack-TPSC Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 63 Breat Pack-TPSC units due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Breat Pack-TPSC, Catalog number 900-3431. 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-0347-2015·2014-12-10

    Customed Urology Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 222 Urology Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Urology Pack, catalog #900-2510 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-0342-2015·2014-12-10

    Customed Cystoscopy Pack III Recalled for Sterility Compromise

    Customed, Inc. is recalling 200 units of Cystoscopy Pack III due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cystoscopy Pack III, catalog #900-2482 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-0270-2015·2014-12-10

    Customed OB Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 224 OB Packs used for patient care procedures due to compromised sterility and inadequate storage conditions that may result in patient infection.

    Product
    OB Pack, Catalog number 900-1030. 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-0309-2015·2014-12-10

    Customed OB Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 120 OB Packs used for wound care due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    OB Pack, Catalog number 900-1717. 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-0280-2015·2014-12-10

    Customed Laparoscopy OB GYN Packs Recalled for Compromised Sterility

    Customed, Inc. is recalling 105 Laparoscopy OB GYN Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy OB GYN Pack, Catalog number 900-1192. 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-0286-2015·2014-12-10

    Customed Neuro Spine Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 207 Neuro Spine Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Neuro Spine Pack, Catalog number 900-1300 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-0373-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 96 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-3178. 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-0310-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 76 Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Cesarean Pack, Catalog number 900-1719. 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-0363-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, catalog #900-2829 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-0242-2015·2014-12-10

    Customed Tracheotomy Care Kits Recalled for Sterility Compromise

    Customed, Inc. is recalling Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Tracheotomy Care Kit, Catalog number 900-110. 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-0353-2015·2014-12-10

    Customed Medical Device Recall for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 129 medical devices due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Hip & Knee Replacement, catalog #900-2614 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-0356-2015·2014-12-10

    Customed Open Heart Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 106 Open Heart Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Open Heart Pack, catalog #900-2618 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-0295-2015·2014-12-10

    Customed Angiography Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 70 Angiography Packs (Catalog 900-1488) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, Catalog number 900-1488. 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-0409-2015·2014-12-10

    Customed C-Section Surgical Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 600 C-Section Surgical Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    C-Section Surgical Pack, Catalog # 900-921A 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-0354-2015·2014-12-10

    Customed Extremity PACK Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 168 Extremity PACKs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Extremity PACK, catalog #900-2615 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-0241-2015·2014-12-10

    Customed Wound Closure Tray II Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Closure Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Closure Tray II, Catalog number 900-064. 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-0279-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 156 Laparoscopy Packs (Catalog 900-1176) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-1176. 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-0404-2015·2014-12-10

    Customed Cesarean Pack Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 264 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cesarean Pack, Catalog # 900-851 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-0413-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 372 Laparotomy Packs (Catalog # 900-996) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states