Customed, Inc Minor Laceration Tray, Catalog number 900-1765. 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
Minor Laceration Tray, Catalog number 900-1765. 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: 111113039 111123389 112010093 112020412 112030646 112041203 112051652 112051882 112062451 112062568 112093753 112114887 113036455 113047208 113057433 113057863 113078277 113088761 113099393 113109754 131110201 131210683 131210763 140111120 140312090 140512615 140513043 140613601 140613631 1121114534
Customed, Inc is recalling Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care pro 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