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.

326–350 of 682

  • SevereFDA (Devices)·Z-0284-2015·2014-12-10

    Customed Premium Laparotomy Pack Recalled for Compromised Sterility

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

    Product
    Premium Laparotomy Pack, Catalog number 900-1296. 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-0305-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 246 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-1688. 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-0369-2015·2014-12-10

    Customed Tummy Tuck Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 18 Tummy Tuck Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Tummy Tuck Pack, Catalog #900-3026 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-0392-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 340 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-620. 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-0329-2015·2014-12-10

    Customed Femoral Pack Recalled Due to Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Femoral Pack, catalog #900-2164 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-0360-2015·2014-12-10

    Customed Knee and Hip Replacement Trays Recalled for Sterility Compromise

    Customed, Inc. is recalling 160 Knee and Hip Replacement trays due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 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-0291-2015·2014-12-10

    Customed Cardiovascular Case Cart Recalled for Compromised Sterility

    Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. 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-0275-2015·2014-12-10

    Customed Recalls Peri Gyn Packs Due to Compromised Sterility

    Customed, Inc. is recalling 740 Peri Gyn Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Peri Gyn Pack, Catalog number 900-1091. 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-0308-2015·2014-12-10

    Customed Peri Gyn Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 180 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Peri Gyn Pack, Catalog number 900-1716. 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-0317-2015·2014-12-10

    Customed Arthroscopy Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 12 Arthroscopy Packs (Catalog 900-1832) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-1832. 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-0384-2015·2014-12-10

    Customed Laparoscopy Packs Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 240 Laparoscopy Packs (Catalog 900-474) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-474. 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-0267-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 1,152 Laparoscopy Packs (Catalog 900-028) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-028. 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-0282-2015·2014-12-10

    Customed Laminectomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 180 Laminectomy Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Laminectomy Pack, Catalog number 900-1202. 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-0278-2015·2014-12-10

    Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 132 Neuro Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Neuro Pack, Catalog number 900-1146. 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-0403-2015·2014-12-10

    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 # 900-848 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-0312-2015·2014-12-10

    Customed Urology Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 40 Urology Packs (Catalog 900-1738) due to compromised sterility and inadequate storage conditions that may result in patient infection.

    Product
    Urology Pack, Catalog number 900-1738. 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-0388-2015·2014-12-10

    Customed Recalls Pery GYN Surgical Packs Due to Sterility Compromise

    Customed, Inc. is recalling 354 Pery GYN Surgical Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Pery GYN Surgical Pack, Catalog number 900-548A. 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-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
  • 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-0332-2015·2014-12-10

    Customed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 880 surgical packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states