Pump, Portable, Aspiration (manual Or Powered)
General, Plastic Surgery · 21 CFR 878.4780
Recent MDR events
968 adverse event reports on file
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07547
- S-SCORT IIIJul 21, 2026DeathSsorc, Inc.MW5190892
- MEDLINEJul 9, 2026MalfunctionMedline Industries, Lp1417592-2026-04854
- MEDLINEJul 9, 2026MalfunctionMedline Industries, Lp1417592-2026-04868
- THOPAZ+ CHEST DRAINAGE SYSJun 24, 2026InjuryMedela Ag3002807523-2026-00002
- MEDLINEJun 22, 2026MalfunctionMedline Industries, Lp1417592-2026-02914
- MEDLINEJun 19, 2026MalfunctionMedline Industries, Lp1417592-2026-02703
- THOPAZ+ CHEST DRAINAGE SYSJun 2, 2026InjuryMedela Ag3002807523-2026-00001
- MEDLINEMay 24, 2026MalfunctionMedline Industries, Lp1417592-2026-01688
- MEDLINEMay 21, 2026MalfunctionMedline Industries, Lp1417592-2026-01622
Event type breakdown
Recalls
21 recall events for this product code
- R A Medical ServicesOpen, ClassifiedSep 20, 2023
MINISCAV (tm) Vacuum Pump
Inadequate documentation of acceptance activity
Z-2619-2023 · View FDA record ↗ - Ohio Medical CorporationTerminatedSep 7, 2018
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC
The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
Z-2995-2018 · View FDA record ↗ - Ohio Medical CorporationTerminatedDec 29, 2010
Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000
The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.
Z-0833-2011 · View FDA record ↗ - Ohio Medical CorporationTerminatedJun 7, 2010
MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corpor
Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
Z-1777-2010 · View FDA record ↗ - Ohio Medical CorporationTerminatedJun 7, 2010
NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709
Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
Z-1778-2010 · View FDA record ↗ - Smith And Nephew, Inc. Wound Management DivisionTerminatedOct 27, 2008
GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China.
External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.
Z-0162-2009 · View FDA record ↗ - Neomedix CorpTerminatedSep 29, 2008
NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.
Z-0071-2008 · View FDA record ↗ - Medtronic NeuromodulationTerminatedSep 4, 2008
Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The V
The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.
Z-2168-2008 · View FDA record ↗ - Smith And Nephew, Inc. Wound Management DivisionTerminatedAug 6, 2008
FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product.
Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.
Z-1620-2008 · View FDA record ↗ - Haemonetics CorporationTerminatedOct 12, 2006
SmartSuction Harmony Powered Suction Device
Faulty circuit board may short circuit and cause electric shock to operator
Z-0035-2007 · View FDA record ↗
Registered firms
158 firms currently registered for this product code
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Ohio Medical Llc
Gurnee, IL, US
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Avita Corporation
San-Chung District, New Taipei City, TW
Think Green Limited
Kumeu Auckland, NZ
Gebruder Renggli, Ag
Schaffhausen, CH
Linamar Innovation Hub
Guelph Ontario, CA
Cro, Llc
Missoula, MT, US
Dre Med
Louisville, KY, US
Shenzhen Desida Technology Co., Ltd.
Shenzhen Guangdong, CN
Sscor, Inc.
Simi Valley, CA, US
Ventec Life Systems, Inc.
Woodinville, WA, US
Hetaida Technology Co., Ltd.
Dongguan Guangdong, CN
Promepla S.a.m
MONACO Monaco-Ville, MC
Uab Kitron
KAUNAS Kauno Apskritis, LT
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Isomedix Operations Inc.
SAN DIEGO, CA, US
Atmos Inc.
Exton, PA, US
Black & Black Surgical, Inc.
Tucker, GA, US
Storz Endoskop Produktions Gmbh
SCHAFFHAUSEN, CH
Drw Medical
Aston, PA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
510(k) clearances
159 clearances for this product code
- Shenzhen Root Innovation Technology Co., Ltd.May 26, 2026
K253629 · Momcozy Nasal Aspirator (BN007)
- Shenzhen Root Innovation Technology Co., Ltd.May 15, 2026
K260134 · Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
- Shenzhen HugeMed Medical Technical Development Co., Ltd.May 14, 2026
K260892 · Suction Pump (SU-90)
- Shenzhen Kingboom Technology Co., Ltd.May 12, 2026
K260473 · Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
- Shenzhen Dongjiang Technology Co., Ltd.Apr 14, 2026
K253107 · Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
- Shenzhen Kingboom Technology Co., Ltd.Mar 13, 2026
K260147 · Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
- Shenzhen Desida Technology Co., Ltd.Jun 6, 2025
K251450 · Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
- Shenzhen Desida Technology Co., Ltd.May 16, 2025
K244033 · Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)