Class II — Summit Medical, Inc.
| Recalling firm | Summit Medical, LLC |
|---|---|
| Registered facility | SUMMIT MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile). |
| Product | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane. |
| Quantity | 9 boxes |
| Distribution | Distributed in MS, NY, PA and TX. |
| Initiated | 2013-03-27 |
| Classified | 2013-05-14 |
| Terminated | 2013-08-06 |
| Recall number | Z-1319-2013 |
| 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 — Summit Medical, Inc. (Z-1319-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65034/
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