FDA Device recall Z-1544-2014

12-Instrument Sterilization Tray

FDA Device
Class II
terminated
Published 2014-05-14

On 2014-05-14 the FDA classified a Class II recall of 12-Instrument Sterilization Tray by Stryker Endoscopy, citing gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1544-2014
Classification	Class II
Status	terminated
Initiated	2014-04-16
Published	2014-05-14
Last updated	2026-09-13 11:53 UTC
Company	Stryker Endoscopy
Distribution	n/a

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.

Reason

Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.

Identifiers

code_info	Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1, 4… 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.

code_info

Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1, 4…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1544-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.