CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report

Stryker Instruments 0400-850-000 T4 Toga, Zipper recalled

Stryker Instruments Div. of Stryker is recalling Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO, distributed nationwide in the US. The recall was initiated on 23 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1005097, 1008188, 1011281, 1103194, 1106465, 1107519, 1005105, 1008192, 1011296, 1103201, 1107501, 1109763, 1005111, 1009198, 1012303, 1103223, 1107550, 1109777, 1005118, 1009213, 1012314, 1104282, 1107560, 1109822, 1006129, 1009219, 1012325, 1104290, 1107605, 1109850, 1008181, 1009220, 1012335, 1104320, 1107606, 1006135, 1010228, 1012344, 1104312, 1108618, 1007145, 1010236, 1101003, 1105346, 1108663, 1007151, 1010235, 1101030, 1105355, 1108677, 1007156, 1010243, 1101055, 1105378, 1108709, 1007163, 1010252, 1102109, 1106411, 1108714, 1007169, 1010260, 1102123, 1105405, 1109728, 1008183, 1011276, 1102141, 1106430, and 1104275.

Quantity recalled88,040 units (8,804 boxes)

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-1502-2013
FDA event ID: 65321
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 23 May 2013
FDA classified: 6 Jun 2013
Reported: 12 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Particulate Matter
Device type: Masks, Gloves & PPE

Timeline

23 May 2013	Recall initiated by company
6 Jun 2013	Classified by FDA	+14 days
12 Jun 2013	Published in enforcement report	+6 days

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

Reason for recall

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Product as listed by the FDA

Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Where it was distributed

USA Nationwide Distribution

Nationwide

Questions about this recall

Is Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO recalled?

Yes. Stryker Instruments Div. of Stryker recalled Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO on 23 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1502-2013.

Why was it recalled?

Which lots are affected?

1005097, 1008188, 1011281, 1103194, 1106465, 1107519, 1005105, 1008192, 1011296, 1103201, 1107501, 1109763, 1005111, 1009198, 1012303, 1103223, 1107550, 1109777, 1005118, 1009213, 1012314, 1104282, 1107560, 1109822, 1006129, 1009219, 1012325, 1104290, 1107605, 1109850, 1008181, 1009220, 1012335, 1104320, 1107606, 1006135, 1010228, 1012344, 1104312, 1108618, 1007145, 1010236, 1101003, 1105346, 1108663, 1007151, 1010235, 1101030, 1105355, 1108677, 1007156, 1010243, 1101055, 1105378, 1108709, 1007163, 1010252, 1102109, 1106411, 1108714, 1007169, 1010260, 1102123, 1105405, 1109728, 1008183, 1011276, 1102141, 1106430, and 1104275.

Where was it sold?

USA Nationwide Distribution

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

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