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.

1–25 of 682

  • SevereFDA (Devices)·Z-1481-2016·2016-04-20

    Customed Laparoscopy-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900618A LAPAROSCOPY-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
  • SevereFDA (Devices)·Z-1453-2016·2016-04-20

    Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues

    Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.

    Product
    Catalog Number: 9002614 HIP AND KNEE REPLACEMENT 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
  • SevereFDA (Devices)·Z-1422-2016·2016-04-20

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001402 PLASTIC SURGERY 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-1487-2016·2016-04-20

    Customed Incision and Drainage Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 800 Incision and Drainage Trays due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900774 INCISION AND DRAINAGE 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-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-1463-2016·2016-04-20

    Customed Cysto TUR Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 72 Cysto TUR Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002899 CYSTO TUR 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-1459-2016·2016-04-20

    Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,450 Urethral Catheter Trays (14FR) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR 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-1451-2016·2016-04-20

    Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 76 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002516 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-1483-2016·2016-04-20

    Customed Fan Fold Sheets Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,920 fan fold sheets distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900633 FAN FOLD SHEET 44 X 58 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-1486-2016·2016-04-20

    Customed Carpal Tunnel Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 162 carpal tunnel surgical packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    Catalog Number: 900742A CARPAL TUNEL LARGE 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-1480-2016·2016-04-20

    Customed Utility Drapes Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 800 units of Utility Drapes with Tape, SMS, due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS 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-1493-2016·2016-04-20

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 25 arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900982 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-1458-2016·2016-04-20

    Customed Recalls Suction Catheter Trays Due to Sterilization Validation Issues

    Customed, Inc. is recalling 5,650 Suction Catheter Trays 14FR with Sodium Chloride 0.9% Irrigation because of inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION 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-1476-2016·2016-04-20

    Customed Wound Management Tray III Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 620 Wound Management Tray III units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900540 WOUND MANAGEMENT TRAY III 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-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-1448-2016·2016-04-20

    Customed Basic Surgical Pack IV Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 units of Basic Surgical Pack IV in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002469 BASIC SURGICAL PACK IV 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-1443-2016·2016-04-20

    Customed Lithotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 150 Lithotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002167 LITHOTOMY 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-1405-2016·2016-04-20

    Customed Wound Closure Tray I Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Wound Closure Tray I units due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900063 WOUND CLOSURE TRAY I 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-1477-2016·2016-04-20

    Customed Basic Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 10 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900547 BASIC 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-1469-2016·2016-04-20

    Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900419 LABOR & DELIVERY 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-1466-2016·2016-04-20

    Customed Basic Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 55 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900345 BASIC 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-1488-2016·2016-04-20

    Customed sterile skin staple remover recalled for sterilization validation issues

    Customed, Inc. is recalling 580 sterile skin staple removers distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900782 SKIN STAPLE REMOVER STERILE 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-1424-2016·2016-04-20

    Customed Wound Management Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 200 Wound Management Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001456 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-1409-2016·2016-04-20

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 16 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001062 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