Z-1544-2014Class II

12-Instrument Sterilization Tray

Name: Z-1544-2014 12-Instrument Sterilization Tray
Creator: Stryker Endoscopy
Published: 2014-04-16
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-04-16 / Terminated / root cause: sterility

FDA source

Stryker Endoscopy began a recall of 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process... on 2014-04-16. FDA classified it as Class II and gives the reason as "Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1544-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Posted: 2014-05-02
Terminated: 2014-08-18
Recalling firm: Stryker Corp.
Product: 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Root cause tag: sterility
FDA root cause: Reprocessing Controls
Action: Stryker sent an Urgent Device Corrections letters dated April 18, 2014 to all US customers via certified mail. Stryker Sales representative and Stryker international distributors were notified with the letter and response card by e-mail. International sites are responsible for notifying customers. The letter identified the affected product, problem, potential hazards and actions to be taken. Customers were instructed to complete and sign the enclosed Acknowledgement of Receipt form and scan and e-mail to [email protected]. For questions call 1-800-624-4422 option 3 or via email at [email protected].
Quantity in commerce: 2591 trays
Distribution: Worldwide distribution
Product codes and lots: Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1, 48639-1-8, 021464-3, 40288-1-1, 43020, 43893-1-6, 27701, 43104-1-1, 36175-1-1, 48956-1-1, 23027, 40629-3-,1, 43622, 43893-1-7, 29129, 43270-1-1, 36421-1-1, 48956-1-1A, 23398, 40721-1-1, 50476, 43893-1-8, 29670, 43523-1-1, 36424-1-1, 51304-1-1, 23542, 41231-4-1, 54990, 43893-1-9, 30250, 43523-1-1A, 37251-1-1, 51304-1-1A, 23846, 41478-1-1, 7J1, 48639-1-2, 30919, 43674-1-1, 37392-1-1, 52123-1-1, 24073, 41745-1-1, 123, 48639-1-3, 3218., 43893-1-1, 37794-1-1, 52956-1-1, 24511, 42086-1-1, 28646-1-1, 48639-1-4, 33226, 43893-1-10, 38867-1-1, 54346-1-1, 26445, 42306-1-1, 29005-1-1, 48639-1-5, 33961, 43893-1-1, 1SS15327, 26843, 42526-1-1, 30384-1-1, 48639-1-7, 35933, 43893-1-12, 37991, 36610, 43893-1-13, 39219, 43893-1-2, 43893-1-14.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1544-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-02

Product code GEI

K935237Class IIStryker Endoscopic Instruments and AccessoriesStryker Endoscopy / cleared 1994-03-21

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)