Customed Utility Drape End Product Recalled for Compromised Sterility
Customed, Inc. is recalling Utility Drape End Products due to compromised sterility and manufacturing deficiencies that may result in patient infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the deficiencies 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury' reports or risks, warranting a Severe classification.
Plain-English summary
Customed, Inc. is recalling Utility Drape End Products, Catalog number 900-582, because of compromised sterility. The recall is not limited to products with potentially damaged packaging. The product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted due to serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These factors increase the risk of contamination and may result in patient infection. The recall involves 9,700 units distributed to Florida, New York, and Puerto Rico.
Affected lot numbers include 112051996, 112114535, 113025779, 113078335, 113099443, 140111073, 140412695, 140613606, and 140714299. Medical facilities and consumers should stop using these products and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 9,700
Distribution
Part of a larger recall action
This product is one of 179 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 179 products in this recall →Related recalls
Same manufacturer · Customed, Inc
See all →- HighCustomed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Femoral Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19