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.

376–400 of 682

  • SevereFDA (Devices)·Z-0318-2015·2014-12-10

    Customed Recalls Hip Orthopedia Packs Due to Compromised Sterility

    Customed, Inc. is recalling 36 Hip Orthopedia Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Hip Orthopedia Pack, Catalog number 900-1835. 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-0303-2015·2014-12-10

    Customed Femoral Pack Recall Due to Compromised Sterility

    Customed, Inc. is recalling 270 Femoral Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Femoral Pack, Catalog number 900-164. 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-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-0246-2015·2014-12-10

    Customed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling specific lots of Surgeon Gown Poly Reinforced Lgc because compromised sterility and inadequate storage conditions may increase the risk of patient infection.

    Product
    Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. 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-0277-2015·2014-12-10

    Customed Foley Catheter Kit Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 1,500 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Foley Catheter Kit, Catalog number 900-1139 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-0276-2015·2014-12-10

    Customed Foley Catheter Kit Recalled for Compromised Sterility

    Customed, Inc. is recalling 9,770 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Foley Catheter Kit, Catalog number 900-1127. 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-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-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
  • 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-0345-2015·2014-12-10

    Customed Transverse Laparotomy Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 204 Transverse Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Transverse Laparotomy Pack (8), catalog #900-2491 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-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
  • SevereFDA (Devices)·Z-0304-2015·2014-12-10

    Customed Labor and Delivery Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 352 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Labor & Delivery Pack, Catalog number 900-168. 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-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
  • 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-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-0254-2015·2014-12-10

    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 Ryder Memorial, Catalog number 900-1456. 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-0262-2015·2014-12-10

    Customed Gown Fabric Reinforced XXL Recalled for Compromised Sterility

    Customed, Inc. is recalling 1,120 units of Gown Fabric Reinforced XXL due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Fabric Reinforced XXL, Catalog number 900-2567. 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-0323-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 57 Laparoscopy Packs (Catalog 900-1967) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-1967. 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-0269-2015·2014-12-10

    Customed Cysto Tur Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 380 Cysto Tur Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Cysto Tur Pack, Catalog number 900-080. 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-0355-2015·2014-12-10

    Customed Shoulder Pack Recalled Due to Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 96 Shoulder Packs (catalog #900-2616) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states