Z-1041-2017Class II

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit...

Name: Z-1041-2017 Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit...
Creator: Smith & Nephew, Inc.
Published: 2016-11-11
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-11-11 / Open, Classified / root cause: design

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound... on 2016-11-11. FDA classified it as Class II and gives the reason as "Lack of 510k clearance for design modification". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1041-2017
Classification: Class II
Status: Open, Classified
Initiated: 2016-11-11
Posted: 2017-01-18
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Lack of 510k clearance for design modification.
Root cause tag: design
FDA root cause: No Marketing Application
Action: On letter sent to all their consignees, Smith & Nephew asked to the consignees to removed all existing Renasys Go NPWT Pumps and returned following the instructions on the letter and also removed the affected power supply units identified on the recall letter. Each consignee needs to complete the Acknowledge
Quantity in commerce: 15,960 units in the US
Distribution: Nationwide
Product codes and lots: Model No. 66800164; All pumps of this model are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1041-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1041-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-01-25	2017-01-18
Z-1042-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-01-25	2017-01-18

Product code OMP

K083375Class IIRenasys Go Negative Pressure Wound TherapySmith & Nephew, Inc. / cleared 2009-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)