Agency classClass IIOur severity:Severe FDA (Devices)·Z-2443-2018·Announced 2018-07-25

NewDeal UNI-CP Medical Devices Recalled Due to Infection Risk

NewDeal SA is recalling specific UNI-CP medical devices because their use may cause superficial or deep infections requiring antibiotic treatment or device removal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of deep infection requiring device removal and IV antibiotics, which aligns with the rubric criterion for 'Severe' (FDA Class II with significant injury/property-damage reports or high-risk medical consequences).

Plain-English summary

NewDeal SA is recalling specific models of the UNI-CP medical device, including model numbers 330021S through 330430S. The recall covers specific lot numbers distributed across 19 states, including California, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington, and Wisconsin.

The recall is being issued because the use of the impacted product may cause a superficial infection requiring oral antibiotics and wound care, or a deep infection requiring intravenous antibiotics and device removal. The source text does not report any specific number of illnesses, injuries, or deaths associated with this recall.

Consumers who have these specific UNI-CP devices should stop using them and contact NewDeal SA for instructions on how to return or dispose of the product. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
Manufacturer: NewDeal SA
Category: Medical Device — Implantable/Invasive Device
Hazard: infection
device-removal

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

330021S - Lot # F8ML
FEDJ & FF38 330023S - Lot # EF05/G
EGNK/G
F8MM
F9J2
FAPZ
FBE8
FBPB
FCFQ
FCJP
FEDK
FF39 & FFH7 330025S - Lot # FAE6
FBPC
FCFR
FCJQ
FEDL & FFH8 330030S - Lot # EMGF/1
ENHN
EPQM-FBE5
FBPD
FBPE

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 5 recalled by NewDeal SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · NewDeal SA

See all →

High
NewDeal TIBIAXYS Medical Device Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
Severe
NewDeal SA Recalls ADVANSYS MLP/DLP Medical Devices Due to Infection Risk
FDA (Devices) · 2018-07-25
High
NewDeal Large QWIX Medical Device Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
Severe
NewDeal ADVANSYS TTC Medical Devices Recalled for Infection Risk
FDA (Devices) · 2018-07-25

Same hazard · infection