American Surgical Ray-Cot Sponges Recalled for Sterility Compromise
American Surgical Company is recalling Ray-Cot sponges because defective packaging may have compromised sterility. The recall covers 28 boxes distributed worldwide.
What this means for you
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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
American Surgical Company is recalling 28 boxes of Ray-Cot 1/2" x 1.5" neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that compromises the sterility of the medical devices.
The affected product is identified by Lot number 2015/11 AJ. The sponges were distributed worldwide, including in the United States, Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Consumers and healthcare facilities should stop using the affected sponges and contact American Surgical Company for further instructions or a replacement.
The recalled product
- Product
- American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 28
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: 2015/11 AJ
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 91 recalled by American Surgical Company 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 91 products in this recall →Related recalls
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