Food, drugs, devices › Stryker Instruments Div. of Stryker Corporation
Device recall: T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation (Portage, MI) initiated this device recall on 23 Feb 2018; FDA lists 11 product records under event 79779, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 23 May 2019. Initiation: voluntary: firm initiated. Stryker Instruments Div. of Stryker Corporation has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stryker Instruments Div. of Stryker Corporation, Portage, MI.
Reason for recall
"Separation of material layers may occur, causing a potential risk of exposure to contaminants."
Distribution
"US Nationwide and Ireland, Japan, South Korea, UK"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1500-2018 | T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment | 34,570 total products | Class II | Terminated | 2 May 2018 |
| Z-1501-2018 | T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1502-2018 | T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1503-2018 | T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1504-2018 | T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1505-2018 | T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1506-2018 | T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1507-2018 | T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1508-2018 | T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1509-2018 | T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
| Z-1510-2018 | T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment | 34570 total products | Class II | Terminated | 2 May 2018 |
Context
Other enforcement events for Stryker Instruments Div. of Stryker Corporation
All 55 events for Stryker Instruments Div. of Stryker Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Separation of material layers may occur, causing a potential risk of exposure to contaminants."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide and Ireland, Japan, South Korea, UK"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.