American Surgical Company Recalls Neurosurgical Sponges Due to Packaging Defect
American Surgical Company is recalling 16 boxes of Mass Eye & Ear Finger Cot Nasal 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 injuries or illnesses have been reported in the source text.
Plain-English summary
American Surgical Company is recalling 16 boxes of Mass Eye & Ear Finger Cot Nasal 2's (Ref Number: 41-04) sponges. These products are used for neurosurgical and nonneurosurgical procedures. The recall is being conducted because the product packaging is defective, which compromises the sterility of the sponges.
The affected lot numbers are 2015/09 AI, 2015/10 CR, 2015/12 BV, and 2015/12 CV. 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 immediately and contact American Surgical Company for instructions on how to return the product.
The recalled product
- Product
- Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 16
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: Lot Number 2015/09 AI 2015/10 CR 2015/12 BV 2015/12 CV
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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