American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 37 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were 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 compromised sterility of medical devices, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 37 boxes of Delicot-J 30 mm x 70 mm sponges (Ref Number: 63-10J). These neurosurgical and nonneurosurgical sponges are subject to recall because the product packaging is defective, which compromises the sterility of the devices.
The affected lot numbers are 2015/10 BH and 2015/11 CC. The products were distributed worldwide, including 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 FDA has classified this as a Class II recall. Users should stop using the affected sponges and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 37
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 BH 2015/11 CC
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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