Surgical neurological sponges recalled for detaching X-ray markers
American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.
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: This is an FDA Class II recall for a surgical device with a defect where a component may detach and potentially be retained in the surgical field. No adverse events or injuries are reported, placing it at the score 3 level per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
American Surgical Company, LLC is recalling 390 units of the Americot 20-01S neurological sponges (available in 1/4" x 1/4" or 6mm x 6mm size). These surgical sponges are used to protect neural tissue during surgery.
The recalled sponges have a defect where the X-ray detectable barium strip (also called a radio-opaque marker) can become detached from the sponge. This marker is used to help surgeons locate the sponges during and after surgery.
If the barium strip detaches, it may remain in the surgical field. This could delay the surgical procedure while the surgeon spends extra time locating and removing the marker. The recall affects sponges distributed to California, Iowa, Illinois, Minnesota, Missouri, New York, Ohio, and Virginia, as well as Australia, Belgium, Hungary, Italy, the Netherlands, Sweden, and the United Kingdom.
If you have received these sponges, contact American Surgical Company, LLC for instructions on returning or replacing the affected units. Do not use the recalled sponges.
The recalled product
- Product
- Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
- Manufacturer
- American Surgical Company, LLC
- Affected units
- 390
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 (6)
- UDI-DI: 10749915000039 Lot Number Expiration Date: 2023/03 AQ 2028/03/31
- 2023/06 AP 2028/06/30
- 2023/10 BO 2028/10/31
- 2023/12 AY 2028/12/31
- 2024/05 AE 2029/05/31
- 2024/06 AQ 2029/06/30
Distribution
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