American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 27 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 recall is classified as FDA Class II. The hazard involves compromised sterility of a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Surgical Company is recalling 27 boxes of Ray-Cot 1.5" x 3" sponges (Ref Number: 60-22). These neurosurgical and nonneurosurgical sponges are being recalled because defective packaging may compromise the sterility of the product.
The affected lots are 2015/10 BV, 2015/10 CC, and 2015/12 CM. The products were distributed nationwide in the United States and internationally to 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 U.S. Food and Drug Administration has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the defect involves the integrity of the sterile packaging.
The recalled product
- Product
- American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 27
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: 2015/10 BV 2015/10 CC 2015/12 CM
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.
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