Z-1500-2018 Class II Terminated
FDA device recall Z-1500-2018 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: 34,570 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
- 34,570 total products
Product Description
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 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
17071877
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1500-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026