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.

76–100 of 682

  • HighFDA (Devices)·Z-1450-2016·2016-04-20

    Customed Minor Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 344 Minor Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1441-2016·2016-04-20

    Customed Knee Arthroscopy Surgical Pack Recalled for Sterilization Defects

    Customed, Inc. is recalling 12 units of Knee Arthroscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1408-2016·2016-04-20

    Customed Peri-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 Peri-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1414-2016·2016-04-20

    Customed Wound Management Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,088 Wound Management Trays because sterilization processes and package integrity were not adequately validated.

    Product
    Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1425-2016·2016-04-20

    Customed REYITO PLUS Urology Surgical Pack Recalled for Sterilization Defects

    Customed, Inc. is recalling 35 units of REYITO PLUS Urology Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1435-2016·2016-04-20

    Customed Laparotomy Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 938 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1491-2016·2016-04-20

    Customed Cataract Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 576 cataract surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1482-2016·2016-04-20

    Customed Recalls Sterile Surgical Towels Due to Sterilization Validation Issues

    Customed, Inc. is recalling 125 sterile surgical towels distributed in Puerto Rico because the sterilization process and package integrity were not adequately validated.

    Product
    Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1465-2016·2016-04-20

    Customed Surgical Gowns Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1411-2016·2016-04-20

    Customed Tracheostomy Care Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,800 tracheostomy care kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1492-2016·2016-04-20

    Customed Strabismus Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling eight Strabismus Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1400-2016·2016-04-20

    Customed Irrigation Trays Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 4,400 irrigation trays with bulb syringes distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1452-2016·2016-04-20

    Customed Arthroscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 18 Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1413-2016·2016-04-20

    Customed Foley Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 380 units of Foley Catheter Trays in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1410-2016·2016-04-20

    Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 80 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1431-2016·2016-04-20

    Customed Femoral Surgical Pack Recall for Sterilization Validation Issues

    Customed, Inc. is recalling 55 femoral surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1457-2016·2016-04-20

    Customed Shoulder Packs Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 39 sterile shoulder packs used for surgical and patient care procedures due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1464-2016·2016-04-20

    Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 304 Obstetrical Surgical Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1449-2016·2016-04-20

    Customed Urology Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 90 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1442-2016·2016-04-20

    Customed Femoral Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 24 femoral surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1407-2016·2016-04-20

    Customed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 140 Cystoscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1472-2016·2016-04-20

    Customed Laparoscopic Gynecology Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 30 units of Laparoscopic Gynecology Surgical Packs due to inadequate sterilization validation and package integrity concerns.

    Product
    Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1470-2016·2016-04-20

    Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 110 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1439-2016·2016-04-20

    Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 168 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1495-2016·2016-04-20

    Customed PERI-GYN Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 units of PERI-GYN Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state