Z-1810-2012 Class II Terminated
FDA device recall Z-1810-2012 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jun 1, 2012 and is designated Class II. 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… The recall status is terminated (terminated Apr 14, 2014). Affected quantity: 16, 846 (last 3 years) 35,492 all years.
Recall details
- Product Type
- Devices
- Report Date
- Jun 20, 2012
- Initiation Date
- Jun 1, 2012
- Termination Date
- Apr 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16, 846 (last 3 years) 35,492 all years
Product description
T4-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.
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.
Distribution pattern
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
Code information
Part 0400-821-000, 0400-841-000,and 0400-851-000 all lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1810-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026