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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95856

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 03, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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)

Z-0807-2025
Recall number
Z-0807-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Corporation
Quantity
14 (Expanded to 21 units on 10/9/25)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

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