Z-1509-2018 Class II Terminated
FDA device recall Z-1509-2018 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, X-Large; Catalog number: 0400-850-000 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: 17061835, 17061838, 17061857, 17071891, 17071904, 17071928, 17102898, 17102943, 17102957, 17102972, 17111362, 17113014, 17113022, 17113038, 17113080, 17113140, 17113205, 17113223
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1509-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026