Food, drugs, devices › Stryker Instruments Div. of Stryker Corporation

Device recall: Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

FDA enforcement event 90448 · Class III · initiated 4 Dec 2018 · status Terminated · terminated 11 Mar 2024

DeviceVoluntary: Firm initiated1 product recordPortage, MI

Stryker Instruments Div. of Stryker Corporation (Portage, MI) initiated this device recall on 4 Dec 2018; FDA lists 1 product record under event 90448, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 11 Mar 2024. 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

"Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard."

Distribution

"US Nationwide."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1394-2022	Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6	51 units	Class III	Terminated	27 Jul 2022

Context

4%of 2018 device events are Class III1,074 events that year

1product record in this eventfirm median: 1

55events on this register for the firm

Other enforcement events for 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
23 Feb 2018	T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment	Device	Class II	11
9 Nov 2017	Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.	Device	Class II	13

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: "Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 Mar 2024. "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.