Class II — American Surgical Company
| Recalling firm | American Surgical Company, LLC |
|---|---|
| Registered facility | AMERICAN SURGICAL COMPANY, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product packaging defective compromising sterility |
| Product | American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges |
| Quantity | 41 Boxes |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom. |
| Initiated | 2016-03-31 |
| Classified | 2016-05-26 |
| Terminated | 2016-10-21 |
| Recall number | Z-1739-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — American Surgical Company (Z-1739-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73734/
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