Z-1231-2013Class II

Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator...

Name: Z-1231-2013 Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator...
Creator: Stryker Endoscopy
Published: 2013-03-27
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-03-27 / Terminated / root cause: labeling and UDI

FDA source

Stryker Endoscopy began a recall of Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site... on 2013-03-27. FDA classified it as Class II and gives the reason as "The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1231-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-27
Posted: 2013-05-03
Terminated: 2013-09-24
Recalling firm: Stryker Corp.
Product: Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 147,921 - all sizes
Distribution: Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
Product codes and lots: Manufacturer Part Number: 250-070-484

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1231-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1218-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1219-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1220-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1221-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1222-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1223-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1224-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1225-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1226-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1227-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1228-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1229-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1230-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1231-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1232-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1233-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1234-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1235-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1236-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1237-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03

Product code GCX

K954726Class IIStryker Strykeflow Suction Irrigator (Modification)Stryker Endoscopy / cleared 1995-11-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)