American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 689 boxes of Delicot sponges because defective packaging may compromise 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Surgical Company is recalling 689 boxes of American Surgical Delicot 30mm x 70mm sponges (Ref: 63-10). These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which may compromise the sterility of the devices.
The affected lots include 2015/08 BH, 2015/09 BP, 2015/10 BM, 2015/11 BL, 2015/12 AX, 2015/12 CR, 2016/01 AN, 2015/08 BZ, 2015/10 AG, 2015/09 AW, 2015/10 CD, 2015/11 AZ, 2015/11 BT, 2015/12 AY, 2015/11 BH, 2015/12 CO, and 2015/12 DD. 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 should stop using these sponges and contact American Surgical Company for further instructions. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 689
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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