Customed Debridement Tray Recalled Due to Sterility Compromise
Customed, Inc. is recalling 50 Debridement Trays (Catalog #900-2702) 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 risk 'may result in patient infection' due to compromised sterility and manufacturing deficiencies. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios that warrant a Severe (4) classification, as it involves a direct risk of serious harm (infection) from a medical device.
Plain-English summary
Customed, Inc. is recalling 50 units of the Bandeja para Debridacion (Debridement Tray), Catalog #900-2702. These trays are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by Lot number 140814785.
The recall is being conducted because of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination. This risk may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who possess these specific trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers 140814785
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