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.

301–325 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-0238-2015·2014-12-10

    Customed Irrigation Tray Recall Due to Compromised Sterility

    Customed, Inc. is recalling Irrigation Trays with Bulb Syringes because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Irrigation Tray With Bulb Syringe, Catalog number 900-020. 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-0374-2015·2014-12-10

    Customed Impervious Gowns Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 240 impervious gowns due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. 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-0239-2015·2014-12-10

    Customed Universal Drainage Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Universal Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Universal Drainage Tray, Catalog number 900-032. 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-0412-2015·2014-12-10

    Customed Arthoscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 120 Arthoscopy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Arthoscopy Pack, Catalog # 900-982 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-0316-2015·2014-12-10

    Customed Laparoscopy Premium Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 28 units of Laparoscopy Premium Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Premium Pack, Catalog number 900-1803. 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-0322-2015·2014-12-10

    Customed Medical Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 160 Higado & Pancrea Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Higado & Pancrea Pack, Catalog number 900-1966. 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-0367-2015·2014-12-10

    Customed Recalls 51 TLIF Packs Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 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-0399-2015·2014-12-10

    Customed Recalls Carpal Tunnel Surgical Packs Due to Sterility Compromise

    Customed, Inc. is recalling 660 Carpal Tunnel Surgical Large Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Carpal Tunnel Surgical Large Pack, Catalog # 900-742A 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-0287-2015·2014-12-10

    Customed Pediatric Lap Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 56 Pediatric Lap Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Pediatric Lap Pack, Catalog number 900-1383 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-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-0281-2015·2014-12-10

    Customed Open Heart Tray Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 71 Open Heart Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Open Heart Tray, Catalog number 900-1196C 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-0362-2015·2014-12-10

    Customed Laparotomy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 852 Laparotomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Surgical Pack, catalog #900-281A 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-0237-2015·2014-12-10

    Customed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 185,000 surgical packs distributed in Florida, New York, and Puerto Rico because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Surgical packs (includes trays, bags and kits) 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-0364-2015·2014-12-10

    Customed Orthopedic Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 300 Orthopedic Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Orthopedic Pack, catalog #900-2830 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-0268-2015·2014-12-10

    Customed Major Laparotomy Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 840 Major Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Major Laparotomy Pack, Catalog number 900-036. 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-0283-2015·2014-12-10

    Customed Premium Cesarean Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 150 Premium Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Premium Cesarean Pack, Catalog number 900-1294 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-0352-2015·2014-12-10

    Customed Arthroscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 75 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Arthroscopy Pack, catalog #900-2609 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-0327-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,068 Angiography Packs due to significant compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, catalog #900-210 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-0389-2015·2014-12-10

    Customed Laparoscopy Cholecystectomy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. 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-0346-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 400 Laparotomy Pack III units due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states