Device recall: Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and…

Class II FDA enforcement event 65321. Recall start date: 23 May 2013. Status in the FDA record: Terminated. Termination date: 14 Apr 2014.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

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

Stryker Instruments Div. of Stryker Corporation started this device recall on 23 May 2013. The firm address in the FDA record is in Portage, MI. FDA put the recall in Class II. FDA event 65321 has 16 product records. The first FDA enforcement report date is 12 Jun 2013. The record gives the status Terminated, with the termination date 14 Apr 2014.

FDA enforcement report The 16 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

USA Nationwide Distribution

Recalling firm

Stryker Instruments Div. of Stryker Corporation, Portage, MI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

16 product records in the event.

FDA event 65321: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1489-2013	Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) 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…	2,980 units (298 boxes)	Class II	Terminated	12 Jun 2013
Z-1490-2013	Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) 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…	48,040 units, ( 4804 boxes)	Class II	Terminated	12 Jun 2013
Z-1491-2013	Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, 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…	1,980 units (198 boxes)	Class II	Terminated	12 Jun 2013
Z-1492-2013	Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular 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…	3,000 units (300 boxes)	Class II	Terminated	12 Jun 2013
Z-1493-2013	Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large 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…	34,640 units (3,464 boxes)	Class II	Terminated	12 Jun 2013
Z-1494-2013	Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large 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…	21,660 units (2166 boxes)	Class II	Terminated	12 Jun 2013
Z-1495-2013	Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) 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…	7960 units (796 boxes)	Class II	Terminated	12 Jun 2013
Z-1496-2013	Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; 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…	334,520 units (33,452 boxes)	Class II	Terminated	12 Jun 2013
Z-1497-2013	Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; 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…	3000 units (300 boxes)	Class II	Terminated	12 Jun 2013
Z-1498-2013	Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; 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…	3,980 units ( 398 boxes)	Class II	Terminated	12 Jun 2013
Z-1499-2013	Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; 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…	25,770 units (2,577 boxes)	Class II	Terminated	12 Jun 2013
Z-1500-2013	Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, 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…	5,000 units ( 500 boxes)	Class II	Terminated	12 Jun 2013
Z-1501-2013	Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, 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…	9,930 units (993 boxes)	Class II	Terminated	12 Jun 2013
Z-1502-2013	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…	88,040 units (8,804 boxes)	Class II	Terminated	12 Jun 2013
Z-1503-2013	Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) 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…	2,000 units ( 200 boxes)	Class II	Terminated	12 Jun 2013
Z-1504-2013	Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, 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…	6,990 units ( 699 boxes)	Class II	Terminated	12 Jun 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 16Median of the firm: 1
Events of the firm on the register: 55

Other events of the firm

Other FDA enforcement events of Stryker Instruments Div. of Stryker Corporation
Initiated	Product (first record)	Type	Class	Records
15 Jun 2022	SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, rec	Device	Class II	1
16 Oct 2020	Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cut	Device	Class II	1
26 Mar 2020	Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smo	Device	Class II	1
22 Jan 2020	Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label	Device	Class II	1
13 Jan 2020	SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches lo	Device	Class II	3
6 Nov 2019	Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connecto	Device	Class II	2
31 Jul 2019	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for	Device	Class II	2
19 Mar 2019	Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are	Device	Class II	1
4 Dec 2018	Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6	Device	Class III	1
23 Feb 2018	T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment	Device	Class II	11

Stryker Instruments Div. of Stryker Corporation: all 55 events

Official channels

FDA enforcement report Z-1489-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 65321. https://recallregister.com/fda/ii/65321/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: USA Nationwide Distribution
What quantity of product is in FDA event 65321?: The event has 16 product records. The first record gives this quantity: 2,980 units (298 boxes)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.