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Richard Wolf GmbH · Model 2207011 · UDI-DI 04055207057100
10
510(k) clearances
2,026
Adverse events (53 deaths)
24
Recalls
63
Facilities
Description
SUCTION PUMP for US Litho 2271, with speed control for pressure setting between 0.1 and 0.6 bar, U: 100-230VAC/ 50/60Hz, Dim. (wxhxd): 320x120x225mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-06 | Stryker Corporation | It 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 |
| 2026-01-13 | Laerdal Medical Corporation | units 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 |
| 2020-12-18 | Laerdal 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 |
| 2017-08-31 | Laerdal Medical Corporation | A 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 |
| 2017-01-08 | Laerdal Medical Corporation | The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged. |
| 2016-07-01 | Stryker Instruments Div. of Stryker Corporation | Stryker 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 |
| 2016-05-23 | DeVilbiss Healthcare LLC | A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. |
| 2015-06-04 | Gardner Denver Thomas Inc | Vacuum pump may not perform to specification. |
| 2015-06-04 | Gardner Denver Thomas Inc | Vacuum pump may not perform to specification. |
| 2015-06-04 | Gardner Denver Thomas Inc | Vacuum pump may not perform to specification. |
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Get your free API keyRead the docsData 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.