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.

1–25 of 682

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-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-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-1429-2016·2016-04-20
Customed Dressing Change Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 550 Dressing Change Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001538 DRESSING CHANGE 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-1440-2016·2016-04-20
Customed Liver and Pancreas Surgery Kits Recalled for Sterilization Issues
Customed, Inc. is recalling 20 liver and pancreas surgery kits due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001966 LIVER & PANCREAS SURGERY 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-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-1415-2016·2016-04-20
Customed Wound Manage II Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling Wound Manage II kits due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001198 WOUND MANAGE II 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-1479-2016·2016-04-20
Customed Lap-Cholecystectomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 144 units of Lap-Cholecystectomy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900576A LAP-CHOLECYSTECTOMY 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-1427-2016·2016-04-20
Customed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 12 units of D&C Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001496 D&C LAPAROSCOPY 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-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-1399-2016·2016-04-20
Customed OB Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 32 OB Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900012 OB 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-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-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-1496-2016·2016-04-20
Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 32 units of Cesarean Section Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900998 CESAREAN SECTION 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-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-1436-2016·2016-04-20
Customed Minor Laceration Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 3,700 Minor Laceration Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001765 MINOR LACERATION 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-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-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-1419-2016·2016-04-20
Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 220 units of Premium Obstetrical Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001297 PREMIUM 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-1434-2016·2016-04-20
Customed Urology Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 25 units of Urology Surgical Packs (Catalog No. 9001738) due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001738 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-1433-2016·2016-04-20
Customed Universal Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Universal Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900169 UNIVERSAL 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-1406-2016·2016-04-20
Customed Wound Closure Tray II Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 600 units of Wound Closure Tray II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900064 WOUND CLOSURE TRAY II 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-1401-2016·2016-04-20
Customed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Category
Medical Device
Distribution
1 state