Z-1878-2013Class II

Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole)

Name: Z-1878-2013 Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole)
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-06-24
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-06-24 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where... on 2013-06-24. FDA classified it as Class II and gives the reason as "A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1878-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-24
Posted: 2013-08-06
Terminated: 2014-01-30
Recalling firm: Stryker Corp.
Product: Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali
FDA root cause: Component change control
Action: Stryker sent an URGENT Medical Device Recall Notice letter dated June 24, 2013 to all affected customers. The letter identified the affected product, product issue, risk to health and actions to be taken. Customers were instructed to locate affected product and hold for upgrade, use enclosed response form to document inventory and receipt of notice, and in case of further distribution forward the recall notice. Stryker will dispatch a technician to perform the upgrade to the affected product. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Kara Spath, Regulatory Affairs 269-389-4518 [email protected].
Quantity in commerce: 215 units total
Distribution: Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.
Product codes and lots: 5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134, 1131900074, 1200500134, 1203200244, 1210100114, 1131300144, 1131900084, 1200500144, 1203200254, 1210100124, 1131300154, 1131900094, 1200500154, 1203200274, 1210100134, 1131300164, 1131900104, 1200500164, 1203700954, 1210100144, 1131300174, 1131900114, 1200500174, 1203700964, 1210100154, 1131300184, 1131900124, 1200500184, 1203700974, 1210700014, 1131300194, 1132800114, 1200500194, 1203900024, 1210700024, 1131300204, 1132800124, 1200500204, 1204000044, 1210700034, 1131300214, 1132800134, 1201300494, 1204000054, 1210700044, 1131300224, 1132800144, 1201300544, 1207400154, 1210700054, 1131300234, 1132800154, 1201300754, 1207400164, 1213800114, 1131300244, 1132800164, 1201300764, 1207400174, 1213800124, 1131900014, 1132800174, 1201300774, 1207400184, 1213800134, 1131900024, 1132800184, 1201300784, 1208300014, 1213800144, 1131900034, 1132800194, 1201300794, 1208300024, 1213800154, 1131900044, 1132800204, 1203200214, 1208300034, 1131900054, 1200500114, 1203200224, 1208300044, 1131900064, 1200500124, 1203200234, 1208300054.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1878-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1878-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1879-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1880-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05

Product code LFL

K010309UnclassifiedSonopet Model Ust-2001 Ultrasonic Surgical AspiratorMutoh America Co., Ltd. / cleared 2001-04-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)