American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.
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 FDA classified this as a Class II recall involving a risk-of-harm product (sterility compromise) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
American Surgical Company is recalling 165 boxes of Ray-Cot 1/4" x 1/4" neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that may compromise the sterility of the sponges.
The affected products are identified by the following lot numbers: 2015/09 AX, 2015/10 BU, 2015/10 BZ, 2015/11 BN, 2015/12 BK, 2015/12 AF, and 2015/12 CL. The sponges were distributed nationwide in the United States and in 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.
The FDA has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 165
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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