Facility

SMITH & NEPHEW (SUZHOU) LIMITED

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007841320
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	No. 12 Wuxiang Road, West Zone Suzhou Jiangsu, CN 21502
Registration status	Active · expires 2026
Parent company	Smith & Nephew (Suzhou) Limited (owner-operator 10034781)
Brand names	CICA-CARE

Activity by year

Recalls (6)

Devices registered here (1)

Elastomer, Silicone, For Scar Management
Product code MDA (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4025

Recalls & enforcement

Class IIOngoing2016-11-11
Lack of 510k clearance for design modification.
Class IIOngoing2016-07-21
Sterility seal integrity failures on the Renasys Sterile Transparent Film
Class IITerminated2014-08-13
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Class IITerminated2014-07-18
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Class IITerminated2014-01-09
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contac…
Class IITerminated2013-11-14
Modification of the bacterial overflow guard (filter) and related changes to product labeling.

All facilities operated by Smith & Nephew (Suzhou) Limited

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SMITH & NEPHEW (SUZHOU) LIMITED (FEI 3007841320) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007841320-smith-nephew-suzhou-limited/

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