Customed, Inc Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Recall
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Brand
Customed, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot numbers: 111103264 112010182 112020504 112030803 112041055 112051992 112062557 112062558 112072803 112093630 112104254 112104360 112114532 112114896 112125100 113026195 113036464 113036803 113057608 113057848 113068173 113088872 113089076 113109851 131210264 131210653 140111125 140211539 140312172 140312383 140513369 140714294 140714515 140814956 140915480
Customed, Inc is recalling Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care due to Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customed products are being recalled because of compromised sterility, 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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, NY, PR
Page updated: Jan 10, 2026