Stryker T4 Zipper Toga Sterile Garment Recall: Risk of Contaminant Exposure
Stryker recalls sterile T4 Zipper Toga (S/M) garments with catalog number 0400-810-000 due to potential material layer separation causing contaminant exposure. Affected items may be at risk of exposure to harmful substances.
Lower-risk recall
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Contact the company
What happened, in plain English
Stryker is recalling sterile T4 Zipper Toga (S/M) garments with catalog number 0400-810-000 because material layers might separate, potentially exposing users to contaminants. This could lead to harmful substance exposure during medical procedures. Read more at govinfonow.com/recall/71874-stryker-t4-zipper-toga-sterile-garment-recall-risk-of-contaminant.
Source Summary by GovInfoNow · govinfonow.com/recall/71874-stryker-t4-zipper-toga-sterile-garment-recall-risk-of-contaminant · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1505-2018
Cite this page
“Stryker T4 Zipper Toga Sterile Garment Recall: Risk of Contaminant Exposure.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71874-stryker-t4-zipper-toga-sterile-garment-recall-risk-of-contaminant. Based on FDA recall #Z-1505-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1505-2018%22&limit=1).
Why it’s dangerous
The sterile garment's material layers can separate, which might allow contaminants to come into contact with the wearer. This could happen during medical procedures where the garment is used to protect against infections.
Who’s affected
Healthcare workers using sterile protective garments in medical settings are most at risk. Patients receiving care from these workers may also be affected if the garment fails during procedures.
How to tell if you have this one
Check for the catalog number 0400-810-000 on the garment. The product is a sterile personal protection garment sold under the T4 Zipper Toga (S/M) model.
- Brand
Stryker- Category
Medical device
All 11 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide and Ireland, Japan, South Korea, UK
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1500-2018 | T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment; 17071877 | 34,570 total products |
| Z-1501-2018 | T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment; Lot numbers: 17113078, 17113132, 17113138 | 34570 total products |
| Z-1502-2018 | T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment; Lot numbers: 17061792 | 34570 total products |
| Z-1503-2018 | T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment; Lot numbers: 17061767, 17061774, 17061780, 17071948, 17102915, 17113082 | 34570 total products |
| Z-1504-2018 | 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 | 34570 total products |
| Z-1505-2018 | T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment; Lot number: 17061794 | 34570 total products |
| Z-1506-2018 | 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 | 34570 total products |
| Z-1507-2018 | 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 | 34570 total products |
| Z-1508-2018 | T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment; Lot numbers: 17113139, 17113204 | 34570 total products |
| Z-1509-2018 | 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 | 34570 total products |
| Z-1510-2018 | T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment; Lot numbers: 17061837, 17061859, 17113164 | 34570 total products |
What to do — step by step
Check Garment Details
Look for the catalog number 0400-810-000 on the sterile T4 Zipper Toga (S/M) garment.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide and Ireland, Japan, South Korea, UK” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1505-2018 (February 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1505-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.