CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report

SurgiCount+ System Application recalled by Stryker Instruments Div. of

Stryker Instruments Div. of Stryker is recalling SurgiCount+ System Application, distributed in Kansas, Maine. The recall was initiated on 15 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI (GTIN): 07613327543094; Serial Numbers: GK404E00828 GK404E00933 GK404E00959 GK404E01157 GK405E00282 GK405E00642 GK405E00671 GK405E00675 GK405E00693 GK405E00707 GK405E00757 GK405E00827 GK405E00857 GK405E00914 GK403E00537 GK404E00494 GK405E00176 GK405E00655 GK405E00723 GK403E00031 GK404E00638 GK404E00640 GK404E00700 GK404E00866 GK404E00887 GK404E00945 GK404E01113 GK404E01119 GK404E01121 GK404E01123 GK404E01170 GK404E01171 GK405E00602 GK49CE00058 GK404E00032 GK404E00034 GK404E00043 GK404E00262 GK404E00287 GK404E00287 211071 211115 211265

Quantity recalled44 units

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-1452-2022
FDA event ID: 90487
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 15 Jun 2022
FDA classified: 21 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

15 Jun 2022	Recall initiated by company
21 Jul 2022	Classified by FDA	+36 days
27 Jul 2022	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

When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.

Where it was distributed

The products were distributed to the following US states: KS and ME.

Kansas Maine

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI (GTIN): 07613327543094; Serial Numbers: GK404E00828 GK404E00933 GK404E00959 GK404E01157 GK405E00282 GK405E00642 GK405E00671 GK405E00675 GK405E00693 GK405E00707 GK405E00757 GK405E00827 GK405E00857 GK405E00914 GK403E00537 GK404E00494 GK405E00176 GK405E00655 GK405E00723 GK403E00031 GK404E00638 GK404E00640 GK404E00700 GK404E00866 GK404E00887 GK404E00945 GK404E01113 GK404E01119 GK404E01121 GK404E01123 GK404E01170 GK404E01171 GK405E00602 GK49CE00058 GK404E00032 GK404E00034 GK404E00043 GK404E00262 GK404E00287 GK404E00287 211071 211115 211265

Where was it sold?

The products were distributed to the following US states: KS and ME.

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.

More recalls from Stryker Instruments Div. of Stryker

All 161

Reported	Class	Recall	Company	Reason	Where
27 Jul 2022Device	CLASS III	Triton Sponge System recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Device Malfunction	Nationwide
27 Jul 2022Device	CLASS II	Triton Canister System (finished part numbers FG recalled	Stryker Instruments Div. of Stryker	Device Malfunction	Nationwide
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
12 Feb 2020Device	CLASS II	Telescopic Smoke Evac Pencil, PB, Coated, Product No. Shktspcl recalled	Stryker Instruments Div. of Stryker	Other	Nationwide

Other Surgical Instruments recalls

All 3,816

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide