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.

226–250 of 682

HighFDA (Devices)·Z-2630-2015·2015-09-09
Customed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 354 units of Laparoscopy-Colorectal Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS 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-2555-2015·2015-09-09
Customed Minor Procedure Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 80 Minor Procedure Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
MINOR PROCEDURE PACK 40/CS 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-2681-2015·2015-09-09
Customed Laparoscopy OB 6/CS Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 36 units of Laparoscopy OB 6/CS devices distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY OB 6/CS 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-2601-2015·2015-09-09
Customed Labor and Delivery Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 344 Labor and Delivery kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LABOR & DELIVERY 4/CS 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-2628-2015·2015-09-09
Customed Ear Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 48 units of Ear Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EAR PACK 3/CS 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-2704-2015·2015-09-09
Customed General Minor PK 5/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 425 units of General Minor PK 5/CS surgical kits due to inadequate validation of sterilization processes and package integrity.
Product
GENERAL MINOR PK 5/CS 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-2586-2015·2015-09-09
Customed Orthopedic Implants Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 81 orthopedic implants distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
IMPLANTE DE ORTHOPEDIA 3/CS 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-2658-2015·2015-09-09
Customed Basic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 432 Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
BASIC PACK 8/CS 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-2614-2015·2015-09-09
Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 360 Ophthalmic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
OPHTHALMIC PACK 6/CS 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-2552-2015·2015-09-09
Customed Laparoscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 339 packs of Laparoscopy PK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PK 3/CS 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-2715-2015·2015-09-09
Customed Laparotomy Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 243 units of Laparotomy Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2569-2015·2015-09-09
Customed Wound Management Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,248 wound management trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND MANAG.TRAY 24/CS 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-2622-2015·2015-09-09
Customed Angiography Packs Recalled for Sterilization Process Validation Deficiencies
Customed, Inc. is recalling 1,128 angiography packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIOGRAPHY PACK CUSTOMED 4/CS 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-2708-2015·2015-09-09
Customed Urology Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 155 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY PACK 5/CS 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-2625-2015·2015-09-09
Customed Lithotomy Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 370 units of Lithotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LITHOTOMY PACK 10/CS 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-2654-2015·2015-09-09
Customed Shoulder Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 177 units of Shoulder Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SHOULDER PACK 3/CS 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-2597-2015·2015-09-09
Customed Retina Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 21 units of Retina Pack 7/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
RETINA PACK 7/CS 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-2703-2015·2015-09-09
Customed Skin Staple Remover Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,180 Skin Staple Remover Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SKIN STAPLE REMOVER KIT 80/CS 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-2682-2015·2015-09-09
Customed Laparoscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 78 units of Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PACK 6/CS 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-2624-2015·2015-09-09
Customed Femoral Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 152 units of Femoral Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
FEMORAL PACK 4/CS 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-2651-2015·2015-09-09
Customed Tummy Tuck and Breast Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 24 Tummy Tuck & Breast Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
TUMMY TUCK & BREAST PACK-RFMHI 6/CS 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-2685-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling sterile gauze sponges due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (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-2572-2015·2015-09-09
Customed Open Heart Trays Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 106 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
OPEN HEART TRAY 1/CS 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-2713-2015·2015-09-09
Customed recalls cataract packs due to sterilization validation issues
Customed, Inc. is recalling cataract packs distributed in Puerto Rico because the company could not adequately validate the sterilization processes and package integrity for these sterile products.
Product
CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2696-2015·2015-09-09
Customed Recalls Peri Gyn Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling 130 units of Peri Gyn Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
Product
PERI GYN PACK 5/CS 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