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.

351–375 of 682

  • SevereFDA (Devices)·Z-0313-2015·2014-12-10

    Customed Urology Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 60 Urology Packs (Catalog 900-1742) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Urology Pack, Catalog number 900-1742. 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-0337-2015·2014-12-10

    Customed Vaginal Procedure Packs Recalled for Sterility Compromise

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

    Product
    Vaginal Procedure Pack, catalog #900-2385 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-0306-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 126 Cesarean Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Cesarean Pack, Catalog number 900-1689. 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-0290-2015·2014-12-10

    Customed Umbilical Vessel Catheter Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling 48 Umbilical Vessel Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Umbilical Vessel Catheter Kit, Catalog number 900-1408. 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-0397-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 490 Cesarean Packs (Catalog # 900-660) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cesarean Pack, Catalog # 900-660 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-0243-2015·2014-12-10

    Customed Suction Catheter Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling Suction Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Suction Catheter Kit, Catalog number 900-277. 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-0380-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 440 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-414. 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-0393-2015·2014-12-10

    Customed Recalls O.R. Towels Due to Sterility Compromise

    Customed, Inc. is recalling 550 O.R. Towels (Catalog 900-629) because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    O.R. Towels, Catalog number 900-629. 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-0411-2015·2014-12-10

    Customed Strabismus And Plastic Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 120 Strabismus And Plastic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Strabismus And Plastic Pack, Catalog # 900-946 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-0378-2015·2014-12-10

    Customed Major Lap Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 1,680 Major Lap Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Major Lap Pack, Catalog number 900-404. 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-0415-2015·2014-12-10

    Customed C-Section Pack Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 122 C-Section Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    C-Section Pack, Catalog # 900-998 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-0293-2015·2014-12-10

    Customed D&C Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 108 D&C Laparoscopy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    D&C Laparoscopy Pack, Catalog number 900-1476. 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-0251-2015·2014-12-10

    Customed Wound Management Trays 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 900-1154. 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-0335-2015·2014-12-10

    Customed Laparoscopy Colorectal Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Colorectal Surgical Pack, catalog #900-2259A 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-0319-2015·2014-12-10

    Customed Ophthalmic Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Ophtalmic Pack, Catalog number 900-1933. 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-0395-2015·2014-12-10

    Customed Recalls Pery Gyn Packs Due to Sterility Compromise

    Customed, Inc. is recalling 475 Pery Gyn Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    Pery Gyn Pack, Catalog number 900-635. 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-0406-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 60 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog # 900-902 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-0343-2015·2014-12-10

    Customed Laparoscopy and Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 240 units of Laparoscopy and Pack (catalog #900-2483) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy and Pack (1)(2), catalog #900-2483 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-0299-2015·2014-12-10

    Customed Urology Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 284 Urology Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Urology Pack, Catalog number 900-1521. 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-0381-2015·2014-12-10

    Customed Labor and Delivery Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 344 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Labor & Delivery Pack, Catalog number 900-419. 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-0379-2015·2014-12-10

    Customed Cesarean Pack Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 260 Cesarean Packs (Catalog 900-410) due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Cesarean Pack, Catalog number 900-410. 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-0292-2015·2014-12-10

    Customed Recalls Reyito Urological Packs Due to Compromised Sterility

    Customed, Inc. is recalling 315 Reyito Urological Packs because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Reyito Urological Pack, Catalog number 900-1460. 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-0288-2015·2014-12-10

    Customed Open Heart Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 108 Open Heart Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states