CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report

100v Neptune 3 Rover Japanese recalled by Stryker

Stryker is recalling 100v Neptune 3 Rover Japanese (0703-003-000) 120v Neptune S Rover (0711-001-000) 230v, distributed in Georgia, Illinois, Washington. The recall was initiated on 3 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes0703 002 000ENG GTIN 07613327382082, Lot Numbers; 2427418723 2427423863 2427418453 2427423873 2427418743 2427419773; 0703 002 000ES GTIN 07613327382068, Lot Numbers: 2427418453; 0703 003 000 GTIN 07613327381948, Lot Numbers: 2427418093 2427418053 2427418073 2427418233 2427418013 2427418723; 0711 001 000 GTIN 07613327576887, Lot Numbers: 2429720623 2429721033 2429720903 2429721203 2429720973 2429721223 2429721023 2303501403 2323610223 2403600253;

Quantity recalled14 (Expanded to 21 units on 10/9/25)

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-0807-2025
FDA event ID: 95856
Recalling firm: Stryker, Portage, MI
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2024
FDA classified: 6 Jan 2025
Reported: 15 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

3 Dec 2024	Recall initiated by company
6 Jan 2025	Classified by FDA	+34 days
15 Jan 2025	Published in enforcement report	+9 days

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

Reason for recall

Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.

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

100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)

Where it was distributed

US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.

Georgia Illinois Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

0703 002 000ENG GTIN 07613327382082, Lot Numbers; 2427418723 2427423863 2427418453 2427423873 2427418743 2427419773; 0703 002 000ES GTIN 07613327382068, Lot Numbers: 2427418453; 0703 003 000 GTIN 07613327381948, Lot Numbers: 2427418093 2427418053 2427418073 2427418233 2427418013 2427418723; 0711 001 000 GTIN 07613327576887, Lot Numbers: 2429720623 2429721033 2429720903 2429721203 2429720973 2429721223 2429721023 2303501403 2323610223 2403600253;

Where was it sold?

US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.

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.

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