Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling specific lots of surgical gowns because the sterilization process and package integrity were not adequately validated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the failure of sterilization validation poses a theoretical risk of infection, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 5,712 units of Catalog Number 900521 Surgical Gowns (SMS Poly-Reinforced, Raglan Sleeve, AAMI Level III, X-Large). These gowns are used by medical staff for surgical procedures and patient care tasks such as wound healing and suture removals.
The recall was initiated because the sterilization processes and package integrity for these products were not adequately validated or qualified before they were released for distribution as sterile. The affected lots were distributed only in Puerto Rico.
Medical facilities and consumers who possess these specific lots should stop using the products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Gowns
- Affected units
- 5,712
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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 100 products in this recall →Related recalls
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