Agency classClass IIOur severity:Severe FDA (Devices)·Z-2445-2018·Announced 2018-07-25

NewDeal SA Recalls ADVANSYS MLP/DLP Medical Devices Due to Infection Risk

NewDeal SA is recalling specific ADVANSYS MLP/DLP models because their use may cause superficial or deep infections requiring medical treatment.

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 intravenous antibiotics and device removal, which aligns with the rubric criteria for Severe severity involving significant injury or hospitalization-level care.

Plain-English summary

NewDeal SA is recalling specific models of the ADVANSYS MLP/DLP medical device. The affected model numbers are 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S, and 181023S. The recall covers specific lot numbers associated with these models, which are distributed across 19 states including California, New York, and Pennsylvania.

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 U.S. Food and Drug Administration has classified this recall as Class II.

Consumers and healthcare providers should check their inventory for the specific model numbers and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by NewDeal SA.

The recalled product

Product: ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
Manufacturer: NewDeal SA
Category: Medical Device — Implantable Device
Hazard: infection

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 (15)

181051S - Lot # FCK9
FG3H & FG3J 181052S - Lot # E8PA/G & EB1H/G 181041S - Lot # F0AS
F0AT & F0AU 181042S - Lot # E8P8/G & EB1F/G 181031S - Lot # E8N2/G
E8NL/G
E8P4/G
E8PS/G
EBKW/G
EBKW/G1 & F8EH 181032S - Lot # E8P5/G
E8P5/G1
E8PT/G
EB1C/G
E8MF/G/Q
E8PQ/G & EBKU/G 181023S - Lot # E8MG/G
E8P3/G
E8PR/G & F8EG

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 →

Severe
NewDeal UNI-CP Medical Devices Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
High
NewDeal TIBIAXYS Medical Device Recalled 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