Radius VSM Disposable NIBP Cuff recalled for rough edges
Masimo Corporation is recalling Radius VSM Disposable NIBP Cuffs (blood pressure cuffs) with lot numbers 21G6S through 25ADF because they may contain rough edges that could cause skin irritation or redness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential for minor skin irritation from rough edges, which represents a low-risk, localized adverse outcome. The recall is precautionary in nature.
Plain-English summary
Masimo Corporation is recalling 1,028 units of the Radius VSM Disposable NIBP Cuff (REF: 4825, 4826) worldwide due to a manufacturing defect. Small and medium size blood pressure cuffs may contain rough edges that could result in skin irritation or redness when in contact with patient skin.
The affected lots include 21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31, E21JWM, E23FVD (REF 4825) and 21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK (REF 4826). In the United States, the device was distributed to Oklahoma, California, Maryland, Massachusetts, New York, Utah, North Carolina, Tennessee, Minnesota, Texas, Ohio, Pennsylvania, and Virginia. International distribution includes Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, and many other countries.
If you have received one of these cuffs, discontinue use and contact Masimo Corporation for a replacement. Report any adverse events or injuries to the FDA's MedWatch program at 1-888-SAFEFDA or at fda.gov/medwatch.
The recalled product
- Product
- Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
- Manufacturer
- Masimo Corporation
- Hazard
- skin-irritation
- rough-edges
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)
- REF/UDI-DI/Lot: 4825/00843997006989/21G6S
- 22JHV
- 23H03
- 23J05
- 24DBV
- 24NGG
- 25ADG
- E21D31
- E21JWM
- E23FVD
- 4826/10843997006993/21HVX
- 22ELB
- 23G31
- 23H04
- 23HWL
- 23J06
- 24DBW
- 24MNP
- 24NGF
- 25ADF
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighCRE Pro Wireguided medical device sterile packaging breach recall
FDA (Devices) · 2026-07-08
- ModeratePowerPICC SV Catheters recalled due to deficient lidocaine manufacturing
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
FDA (Devices) · 2026-07-08
- ModerateMedela ENFit ExSet Enteral Extension Set Connector Compatibility Issue
FDA (Devices) · 2026-07-08