CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

T4 Pullover Toga, X-Large recalled by Stryker Instruments Div. of

Stryker Instruments Div. of Stryker is recalling T4 Pullover Toga, X-Large, distributed nationwide in the US. The recall was initiated on 23 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 17061775, 17061781, 17061784, 17061793, 17102891, 17102916, 17102925, 17102995, 17113013, 17113083, 17113190

Quantity recalled34570 total products

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1504-2018
FDA event ID: 79779
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 23 Feb 2018
FDA classified: 24 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Feb 2018	Recall initiated by company
24 Apr 2018	Classified by FDA	+60 days
2 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Product as listed by the FDA

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

Where it was distributed

US Nationwide and Ireland, Japan, South Korea, UK

Nationwide

Questions about this recall

Why was it recalled?

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Which lots are affected?

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

Where was it sold?

US Nationwide and Ireland, Japan, South Korea, UK

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

10 other products · FDA event 79779

This product is part of a recall event; the main page for the event is T4 Zipper Toga (S/M) recalled by Stryker Instruments Div. of.

Reported	Class	Recall	Company	Reason	Where
2 May 2018	CLASS II	T4 Zipper Toga (S/M) recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T4 Zipper Toga, X-Large recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T5 Zipper Toga with Peel-Away Face Shield, (XL/T) recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T4 Pullover Toga, L/XL recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T4 Zipper Toga, Regular recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T4 Zipper Toga, (L/XL) recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T4 Pullover Toga, (S/M) recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T4 Pullover Toga, Regular recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T4 Pullover Toga, Large recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
2 May 2018	CLASS II	T5 Zipper Toga with Peel-Away Face Shield, (L/XL) recalled	Stryker Instruments Div. of Stryker	Other	Nationwide

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All 161

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18 Nov 2020Device	CLASS II	Stryker Zyphr Disposable Cranial Perforator recalled	Stryker Instruments Div. of Stryker	Foreign Material	Nationwide
6 May 2020Device	CLASS II	Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	MI

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