NewDeal Large QWIX Medical Device Recalled Due to Infection Risk
NewDeal SA is recalling Large QWIX 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (infection requiring antibiotics or device removal) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
NewDeal SA is recalling Large QWIX medical devices, including model numbers 111740S through 121820S. 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 was initiated 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 specify the number of units affected or report any specific illnesses or injuries to date.
Consumers who have purchased or are using these specific model numbers and lot numbers should stop using the product and contact NewDeal SA for further instructions on the recall.
The recalled product
- Product
- Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S…
- Manufacturer
- NewDeal SA
- Hazard
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)
- 111740S - Lot # F6H4
- F70W
- F9B8
- F9MY
- FAJ6
- FATG
- FBHN
- FC9D
- FD33
- FD34
- FD35
- FDQR
- FDQS
- FELG
- FEW0
- FF8X
- FGA8
- FGCS
- FH80 111745S - Lot # F6H5
- F8S3
Distribution
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 →Related recalls
Same manufacturer · NewDeal SA
See all →- SevereNewDeal UNI-CP Medical Devices Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
- HighNewDeal TIBIAXYS Medical Device Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
- SevereNewDeal SA Recalls ADVANSYS MLP/DLP Medical Devices Due to Infection Risk
FDA (Devices) · 2018-07-25
- SevereNewDeal ADVANSYS TTC Medical Devices Recalled for Infection Risk
FDA (Devices) · 2018-07-25
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateMetrex Recalls CaviWipes Extra Large Due to Packaging Contamination
FDA (Devices) · 2017-03-15
- HighSomatex TUMARK Q Medical Device Recalled for Sterility Risk
FDA (Devices) · 2018-01-31
- ModerateApplied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter
FDA (Devices) · 2012-10-03
- HighFDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Specification Failure
FDA (Devices) · 2015-07-08
- ModerateAVID Medical Recalls Major Packs Due to Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- HighFDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Defects
FDA (Devices) · 2015-07-08