Z-1319-2013Class II

Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest...

Name: Z-1319-2013 Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest...
Creator: Summit Medical, Inc.
Published: 2013-03-27
License: https://open.fda.gov/license/

Summit Medical, LLC / initiated 2013-03-27 / Terminated / root cause: manufacturing process

FDA source

Summit Medical, Inc. began a recall of 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... on 2013-03-27. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1319-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-27
Posted: 2013-05-14
Terminated: 2013-08-06
Recalling firm: Summit Medical, LLC
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.
Product code: JYO Knife, Ear
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Summit Medical sent a Medical Device Recall letter dated March 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately examine your inventory, and quarantine the product subject to this recall. Please complete and return the enclosed "Recall Response Form" as soon as possible. The fax number is (651) 789-3961. For further questions please call (651) 789-3921.
Quantity in commerce: 9 boxes
Distribution: Distributed in MS, NY, PA and TX.
Product codes and lots: Lot No. 121012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1319-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-14

Product code JYO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)