American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 27 boxes of Delicot-J sponges because defective packaging may compromise sterility.
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 involves a medical device where defective packaging compromises sterility, creating a risk of infection (risk-of-harm product) without reported injuries, which aligns with the High severity criteria.
Plain-English summary
American Surgical Company is recalling 27 boxes of Delicot-J 5 mm x 8 mm sponges (Ref Number: 63-01J, Japan Only). These neurosurgical and nonneurosurgical sponges 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.
The recall was initiated because the product packaging is defective, which may compromise the sterility of the sponges. The affected lot number is 2015/10 BS.
Healthcare facilities and consumers should stop using these sponges and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) 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 BS
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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