American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 99 boxes of Delicot 4 mm x 50 mm 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 the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
American Surgical Company is recalling 99 boxes of American Surgical Delicot 4 mm x 50 mm sponges, Reference Number 63-05. These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which compromises the sterility of the devices.
The affected lot numbers are 2015/10 AQ, 2015/10 BC, 2015/10 BW, 2015/11 AK, 2015/11 CJ, 2015/12 AH, and 2015/12 CH. 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 further instructions or a return.
The recalled product
- Product
- American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 99
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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