Z-1439-2013Class II

GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS...

Name: Z-1439-2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS...
Creator: Gyrus Acmi, Incorporated
Published: 2013-05-24
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2013-05-24 / Terminated / root cause: manufacturing process

FDA source

Gyrus Acmi, Incorporated began a recall of GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA... on 2013-05-24. FDA classified it as Class II and gives the reason as "lack of sterility assurance". 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-1439-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Posted: 2013-05-31
Terminated: 2014-05-30
Recalling firm: Gyrus ACMI, Inc.
Product: 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.
Product code: LRC Instrument, Ent Manual Surgical
Reason for recall: lack of sterility assurance
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Cyrus ACMI notified their direct accounts of the recall by Priority Mail with delivery confirmation on May 24, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and immediately cease any further use of any affected product they may have, remove it from inventory, and quarantine it until they ship it back to the firm. For questions customers were instructed to contact their Olympus customer service representative at 1-800-848-9024 to obtain a Returned Goods Authorization so that they may return the product with no charge to them. Customers were asked to note on the enclosed questionnaire that they have received this information and fax it to 484-896-7128. For questions regarding this recall call 508-804-2739.
Quantity in commerce: 100 boxes of 6 units
Distribution: Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
Product codes and lots: JC477666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1439-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1439-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-05-31

Product code LRC

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)