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Neptune 2

STRYKER CORPORATION · Model 0702025000 · UDI-DI 07613154688296

JCX Prescription
10
510(k) clearances
2,026
Adverse events (53 deaths)
24
Recalls
63
Facilities

Description

Single Port Manifold

Recalls

DateFirmReason
2026-05-06Stryker CorporationIt has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being ship
2026-01-13Laerdal Medical Corporationunits manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Categor
2020-12-18Laerdal Medical (Suzhou) Co., Ltd.Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenar
2017-08-31Laerdal Medical CorporationA shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms
2017-01-08Laerdal Medical CorporationThe On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
2016-07-01Stryker Instruments Div. of Stryker CorporationStryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if hi
2016-05-23DeVilbiss Healthcare LLCA small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
2015-06-04Gardner Denver Thomas IncVacuum pump may not perform to specification.
2015-06-04Gardner Denver Thomas IncVacuum pump may not perform to specification.
2015-06-04Gardner Denver Thomas IncVacuum pump may not perform to specification.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.