Customed Irrigation Tray Recall Due to Compromised Sterility
Customed, Inc. is recalling Irrigation Trays with Bulb Syringes because compromised sterility and manufacturing deficiencies may result in patient infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the compromised sterility 'may result in patient infection.' Under the severity rubric, a risk of harm where injury has not yet been reported is classified as High (3), but the explicit mention of a serious health outcome (infection) from a sterile medical device elevates the risk profile to Severe (4) due to the potential for significant injury.
Plain-English summary
Customed, Inc. is recalling 76,800 units of the Irrigation Tray With Bulb Syringe, Catalog number 900-020. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because of compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Specific lot numbers are listed in the agency's recall record. Medical facilities and consumers should stop using these products and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 76,800
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 →- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
Similar recalls
- HighCustomed Irrigation Trays Recalled for Sterilization Validation Deficiencies
FDA (Devices) · 2016-04-20
- HighCustomed Irrigation Trays Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Incision and Drainage Trays Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Recalls Suction Catheter Trays Due to Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Incision and Drainage Trays Recalled for Sterilization Defects
FDA (Devices) · 2015-09-09
- HighCustomed Wound Management Tray Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20