FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
- Recall number
- Z-1510-2018
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
- Status
- Terminated
- Initiated
- 2018-02-23
- Posted
- not on file
- Terminated
- 2019-05-23
- Reason
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Root cause
- Nonconforming Material/Component
- Action
- On March 7, 2018 Stryker Instruments mailed Urgent Medical Device Recall Notifications to affected customers. Distributors and Sales Representative were notified via e-mail. Customers were instructed to: 1) Immediately review this Recall Notification; 2) Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any affected T4 and T5 Togas; 3) Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Fax the completed BRF to Stryker Instruments at 866-521-2762, or email to kara.spath@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification; 4) If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF; 5) If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you and should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Customer with questions or concerns may call (800)253-3210.
- Quantity
- 34570 total products
- Distribution
- US Nationwide and Ireland, Japan, South Korea, UK
- Lot, serial or model codes
- Lot numbers: 17061837, 17061859, 17113164
- 510(k) numbers
- ["K070078"]
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 1811755
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28