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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65486

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 24, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Instruments Div. of Stryker Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-1878-2013
Recall number
Z-1878-2013
Initiated
June 24, 2013
Classification
Class II
Status
Terminated
Quantity
215 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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.

Distribution pattern

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.

device · product 2 of 3

Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) 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.

Z-1879-2013
Recall number
Z-1879-2013
Initiated
June 24, 2013
Classification
Class II
Status
Terminated
Quantity
215 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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

Code information

5450-851-000(Console 100V) S/N 1127900134, 1133400114, 1202400224, 1205800094, 1226800284, 1127900144, 1133400124, 1202400234, 1205800104, 1226800294, 1127900154, 1133400134, 1202400244, 1206200574, 1226800304, 1127900164, 1133400144, 1203700594, 1206200584, 1228500194, 1127900174, 1133400154, 1203700604, 1206200594, 1228500204, 1127900184, 1133900014, 1205100514, 1222800034, 1228500214, 1127900194, 1133900024, 1205100524, 1222800044, 01J0018, 1127900204, 1133900034, 1205100534, 1224800314, 02B0052, 1130500054, 1133900044, 1205100544, 1225500084, 02G0091, 1130500064, 1133900054, 1205100554, 1225500094, 05H0386, 1130500074, 1201300384, 1205100564, 1225500104, 1130500084, 1202400154, 1205100574, 1225500114, 1130800374, 1202400164, 1205100584, 1225500124, 1130800384, 1202400174, 1205100594, 1226800234, 1130800394, 1202400184, 1205100604, 1226800244, 1130800404, 1202400194, 1205800064, 1226800254, 1130800414, 1202400204, 1205800074, 1226800264, 1130800424, 1202400214, 1205800084, 1226800274.

Distribution pattern

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.

device · product 3 of 3

Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) 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.

Z-1880-2013
Recall number
Z-1880-2013
Initiated
June 24, 2013
Classification
Class II
Status
Terminated
Quantity
215 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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

Code information

5450-852-000 (Console 230V) with SN: 1134000114, 1206800484 1210900274, 1134000124, 1206800494, 1210900284,1134000134 1206800504, 1210900294, 1134000144, 1206800514, 1210900304, 1134000154, 1206800524, 1211800064, 1134000164, 1206800534, 1211800074, 1134000174, 1206800544, 1211800084, 1134000184, 1208700014, 1211800094, 1134000194, 1208700024, 1212900014, 1134000204, 1208700034, 1213100114, 1201700324, 1208700044, 1213100124, 1201700334, 1208700054, 1213100134, 1201700344, 1209400164, 1213100144, 1201700354, 1209400174, 1213100154, 1201700364, 1209400184,1206500014, 1209400194, 1206500024, 1209400204, 1206500034, and 1210900264.

Distribution pattern

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.