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.

426–450 of 682

  • HighFDA (Devices)·Z-0349-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 64 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0301-2015·2014-12-10

    Customed Universal Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 156 Universal Packs (Catalog 900-1587) because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0260-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0263-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 2,240 surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0252-2015·2014-12-10

    Customed Wound Management Tray II Recalled for Compromised Sterility

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

    Product
    Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0245-2015·2014-12-10

    Customed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling Surgeon Reinforced Gowns XL because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0294-2015·2014-12-10

    Customed ENT Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 140 ENT Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (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
  • HighFDA (Devices)·Z-0324-2015·2014-12-10

    Customed Orthopedic Trays Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 36 orthopedic trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (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
  • HighFDA (Devices)·Z-0264-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 2,670 surgical gowns because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (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
  • HighFDA (Devices)·Z-0350-2015·2014-12-10

    Customed OB Packs Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 80 OB Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0321-2015·2014-12-10

    Customed Endovenous Custom Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 35 Endovenous Custom Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0390-2015·2014-12-10

    Customed Laparoscopy Gyn Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 160 Laparoscopy Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0258-2015·2014-12-10

    Customed Wound Management Tray Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0247-2015·2014-12-10

    Customed Wound Management Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Wound Management Tray III units because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0250-2015·2014-12-10

    Customed Skin Staple Removal Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0300-2015·2014-12-10

    Customed Dressing Change Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling 1,050 Dressing Change kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Dressing Change, Catalog number 900-1538. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0297-2015·2014-12-10

    Customed D&C Laparoscopy Packs Recalled for Compromised Sterility

    Customed, Inc. is recalling 176 D&C Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (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
  • HighFDA (Devices)·Z-0253-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 4,710 surgical gowns because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0338-2015·2014-12-10

    Customed Total Hysterectomy Kits Recalled for Sterility Compromise

    Customed, Inc. is recalling six Total Hysterectomy kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Total Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0261-2015·2014-12-10

    Customed Recalls Surgical Gowns Due to Compromised Sterility

    Customed, Inc. is recalling 2,520 surgical gowns because compromised sterility and inadequate storage conditions may increase the risk of patient infection.

    Product
    Gown Surgical Non Reinforced XXL, Catalog number 900-2566. 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-2427-2014·2014-09-10

    Customed Recalls O.B. Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY AB
    Category
    Medical Device
    Distribution
    Distributed nationwide