Home / Recalls / Summit Medical, Inc. / Z-1319-2013

Z-1319-2013 Class II Terminated

Recalled by Summit Medical, Inc. — Eagan, MN

FDA device recall Z-1319-2013 was initiated by Summit Medical, Inc. on Mar 27, 2013 and is designated Class II. Reason for recall: 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). The recall status is terminated (terminated Aug 6, 2013). Affected quantity: 9 boxes.

Recall details

Product Type: Devices
Report Date: May 22, 2013
Initiation Date: Mar 27, 2013
Termination Date: Aug 6, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9 boxes

Product description

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.

Reason for recall

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).

Distribution pattern

Distributed in MS, NY, PA and TX.

Code information

Lot No. 121012

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1319-2013
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.