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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Stryker Instruments Div. of Stryker Corporation: Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Agency Publication Date: April 24, 2018
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Affected Products

Product: T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment

17071877

Product: T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment

Lot numbers: 17113078, 17113132, 17113138

Lot Numbers:
numbers
Product: T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment

Lot numbers: 17061792

Lot Numbers:
numbers
Product: T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment

Lot numbers: 17061767, 17061774, 17061780, 17071948, 17102915, 17113082

Lot Numbers:
numbers
Product: T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment

Lot numbers: 17061775, 17061781, 17061784, 17061793, 17102891, 17102916, 17102925, 17102995, 17113013, 17113083, 17113190

Lot Numbers:
numbers
Product: T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment

Lot number: 17061794

Lot Numbers:
number
Product: T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

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

Lot Numbers:
numbers
Product: T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

Lot numbers: 17061816, 17061836, 17061839, 17061853, 17071921, 17072017, 17102944, 17102948, 17113081, 17113141, 17113194

Lot Numbers:
numbers
Product: T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment

Lot numbers: 17113139, 17113204

Lot Numbers:
numbers
Product: T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment

Lot numbers: 17061835, 17061838, 17061857, 17071891, 17071904, 17071928, 17102898, 17102943, 17102957, 17102972, 17111362, 17113014, 17113022, 17113038, 17113080, 17113140, 17113205, 17113223

Lot Numbers:
numbers
Product: T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment

Lot numbers: 17061837, 17061859, 17113164

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79779
Status: Resolved
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Manufactured In: United States
Units Affected: 11 products (34,570 total products; 34570 total products; 34570 total products; 34570 total products; 34570 total products; 34570 total products; 34570 total products; 34570 total products; 34570 total products; 34570 total products; 34570 total products)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.