Customed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 185,000 surgical packs distributed in Florida, New York, and Puerto Rico 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 recall is classified as FDA Class I, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. The source explicitly states the risk may result in patient infection.
Plain-English summary
Customed, Inc. is recalling 185,000 surgical packs, including trays, bags, and kits, used by medical staff for patient care procedures such as wound healing, suture removals, and wound irrigation. The affected products were distributed in Florida, New York, and Puerto Rico.
The recall is being conducted because the products have compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (Quality System Regulation) and uncontrolled and inadequate storage conditions increase the risk of contamination. This risk may result in patient infection.
Medical staff and facilities that have received these products should stop using them immediately. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice and contact Customed, Inc. for further instructions on disposal or replacement.
The recalled product
- Product
- Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 185,000
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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