American Surgical Ray-Cot Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall affects 266 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 is classified as FDA Class II. The hazard involves a risk-of-harm product (sterile sponges) where the packaging defect compromises sterility, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
American Surgical Company is voluntarily recalling 266 boxes of Ray-Cot 1/2" x 1/2" neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that may compromise the sterility of the sponges.
The affected product includes specific lot numbers: 2015/08 AO, 2015/09 BU, 2015/11 BW, 2015/12 BX, and 2015/12 DN. The sponges were distributed nationwide in the United States and in numerous countries, including Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, the Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected sponges and contact American Surgical Company for further instructions. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 266
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: 2015/08 AO 2015/09 BU 2015/11 BW 2015/12 BX 2015/12 DN
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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