Z-1506-2018 Class II Terminated
FDA device recall Z-1506-2018 was initiated by Stryker Instruments Div. Of Stryker Corporation on Feb 23, 2018 and is designated Class II. Reason for recall: Separation of material layers may occur, causing a potential risk of exposure to contaminants. The recall status is terminated (terminated May 23, 2019). Affected quantity: 34570 total products.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Feb 23, 2018
- Termination Date
- May 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34570 total products
Product Description
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Reason for Recall
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Distribution Pattern
US Nationwide and Ireland, Japan, South Korea, UK
Code Information
Lot numbers: 17061810, 17061814, 17071878, 17071903, 17071918, 17071920, 17071949, 17071960, 17071970, 17071974, 17071997, 17072002, 17072006, 17072016, 17102897, 17102926, 17102936, 17102942, 17102956, 17102971, 17102994, 17102996, 17113021, 17113034, 17113037, 17113084, 17113133, 17113191, 17113197, 17113203, 17113221
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1506-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026