American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges because defective packaging compromises sterility.
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 defect compromises sterility, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for theoretical risk without reported harm.
Plain-English summary
American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges, Reference Number 60-12. These neurosurgical and nonneurosurgical sponges are affected by a defect in the product packaging that compromises sterility.
The affected lots are 2015/09 BB and 2015/12 BM. The products 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.
Healthcare facilities and consumers should stop using these sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 102
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: 2015/09 BB 2015/12 BM
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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