Customed Medical Device Recall for Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 129 medical devices due to compromised sterility and manufacturing deficiencies that may cause 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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. The source explicitly states that the deficiencies may result in patient infection, representing a serious health risk.
Plain-English summary
Customed, Inc. is recalling 129 units of medical devices, identified by catalog number 900-2614, due to significant compromised sterility. The recall is driven by serious deficiencies in manufacturing processes and uncontrolled storage conditions that increase the risk of contamination.
The affected devices are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The compromised sterility is not limited to potentially damaged packaging, meaning the risk of patient infection exists even if the external packaging appears intact.
The recall covers units distributed to Florida, New York, and Puerto Rico. Affected lot numbers are 140312137, 140513134, and 140613729. Medical facilities should stop using these devices and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 129
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 140312137 140513134 140613729
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.
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