CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report

BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P recalled

Summit Medical is recalling BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815, distributed in Mississippi, New York, Pennsylvania, Texas. The recall was initiated on 27 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 121012

Quantity recalled9 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1319-2013
FDA event ID: 65034
Recalling firm: Summit Medical, Eagan, MN
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2013
FDA classified: 14 May 2013
Reported: 22 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Mar 2013	Recall initiated by company
14 May 2013	Classified by FDA	+48 days
22 May 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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.

Where it was distributed

Distributed in MS, NY, PA and TX.

Mississippi New York Pennsylvania Texas

Questions about this recall

Why was it recalled?

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).

Which lots are affected?

Lot No. 121012

Where was it sold?

Distributed in MS, NY, PA and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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