CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report

Myringotomy Knife Disposable, Sickle Blade Flat Handle recalled

Gyrus Acmi, Incorporated is recalling Myringotomy Knife Disposable, Sickle Blade Flat Handle, distributed nationwide in the US. The recall was initiated on 24 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesJC477666

Quantity recalled100 boxes of 6 units

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-1439-2013
FDA event ID: 65255
Recalling firm: Gyrus Acmi, Incorporated, Southborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 24 May 2013
FDA classified: 31 May 2013
Reported: 12 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

24 May 2013	Recall initiated by company
31 May 2013	Classified by FDA	+7 days
12 Jun 2013	Published in enforcement report	+12 days

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

Reason for recall

lack of sterility assurance

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

Where it was distributed

Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

lack of sterility assurance

Which lots are affected?

JC477666

Where was it sold?

Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.

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

More recalls from Gyrus Acmi, Incorporated

All 6

Reported	Class	Recall	Company	Reason	Where
6 Jun 2018Device	CLASS II	Reusable Active Cord for Bovie/ValleyLab Generators recalled	Gyrus Acmi, Incorporated	Sterility	Nationwide
17 Jun 2015Device	CLASS II	Diego Elite Tubeset recalled by Gyrus Acmi, Incorporated	Gyrus Acmi, Incorporated	Sterility	Nationwide
17 Jun 2015Device	CLASS II	Diego Elite Tubeset, intended for cutting, coagulation recalled	Gyrus Acmi, Incorporated	Sterility	Nationwide
3 Dec 2014Device	CLASS II	Disposable Falope-Ring Band Applicator Kits recalled	Gyrus Acmi, Incorporated	Lead & Heavy Metals	Nationwide
28 Nov 2012Device	CLASS II	Parparella-type Vent Tube, Silicone recalled by Gyrus Acmi, Incorporated	Gyrus Acmi, Incorporated	Sterility	KS

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