Z-1500-2013Class II

Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use

Name: Z-1500-2013 Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-05-23
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-05-23 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient... on 2013-05-23. FDA classified it as Class II and gives the reason as "Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1500-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-23
Posted: 2013-06-06
Terminated: 2014-04-14
Recalling firm: Stryker Corp.
Product: Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Product code: FYA Gown, Surgical
Reason for recall: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker sent an Urgent Urgent Recall noitifications letter dated May 7, 2013 via certified US mail and E-mail l to all affected customers, distributors and direct accounts. The letter identified the affected products, problem, risk to health, and actions to be taken. Customers were instructed to check inventory, immediately quarantine any affected product, and open each package before discarding to prevent use. Customers were directed to fill out and return a Business Reply Form to Stericycle, Phone: 888-943-2396 Fax: 888-943-4192, Email: [email protected] verifying directions and confirming recalled product was destroyed. For questions call 269-389-4354 or 269-389-4518.
Quantity in commerce: 5,000 units ( 500 boxes)
Distribution: USA Nationwide Distribution
Product codes and lots: 1006141, 1012303, 1102110, 1104324, and 1108664

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1500-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1489-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1490-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1491-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1492-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1493-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1494-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1495-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1496-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1497-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1498-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1499-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1500-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1501-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1502-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1503-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1504-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code FYA

K070078Class IIStryker T4 Hytrel TogaStryker Instruments, Instruments Div. / cleared 2007-02-02

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)