Z-1809-2012Class II

T5 Hytrel Zipper Toga

Name: Z-1809-2012 T5 Hytrel Zipper Toga
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2012-06-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2012-06-01 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to... on 2012-06-01. FDA classified it as Class II and gives the reason as "The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has...". 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-1809-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Posted: 2012-06-14
Terminated: 2014-04-14
Recalling firm: Stryker Corp.
Product: T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Product code: FYA Gown, Surgical
Reason for recall: The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker sent the May 29,2012 URGENT MEDICAL DEVICE RECALL NOTIFICATION and the June 14, 2012 REVISED URGENT MEDICAL DEVICE RECALL Notice to all consignees. The letters identified the affected products, problem and actions to be taken. The Revised letter instructed customers to find, quarantine, make product unusable and destroy all implicated product . Replacement products may not immediately available. Customers were asked to complete and sign the Business Reply Form (BFR) and fax to Stryker Instruments Regulatory Department at 866-521-2762. If the affected products have been further distributed, forward this notification letter and the attached BRF to all affected locations. Questions should be addressed to Angela Ragainis, 269-389-4354; [email protected]
Quantity in commerce: 23,653 ( past 3 years) 47937 all years
Distribution: Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND
Product codes and lots: Part 0400-821-100, 0400-841-100 , 0400-851-100 0400-851-100S1, and 0400-851-100S2 all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1809-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-14
Z-1810-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-14

Product code FYA

K944393Class IIStryker Steri-Shield Surgical ApparelStryker Corp. / cleared 1995-08-28

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)