Consumer Alerts TrackerIndependent U.S. recall decision aid
How it works Search recalls
Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 8, 2026

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Full official product description

Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Radius VSM ECG pre-connected Set, REF: 4842, 4695; Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

Identifiers to compare

  • Lot 4842/10843997011003/25AJH
  • Lot 4825/00843997006989/21G6S
  • Lot 25KMA
  • Lot 25BBJ
  • Lot 25DMH
  • Lot 25FBR
  • Lot 24KLV
  • Lot 24N17
  • Lot 25AGZ
  • Lot 25D1
  • Lot 22JHV
  • Lot 23H03
  • Lot 23J05
  • Lot 24DBV
  • Lot 24NGG
  • Lot 25ADG
  • Lot E21D31
  • Lot E21JWM
  • Lot E23FVD
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Radius VSM ECG pre-connected Set, REF: 4842, 4695REF/UDI-DI/Lot: 4842/10843997011003/25AJH, 25KMA, 25MSC 4695/10843997016015/24N17, 25BBJ, 25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF772Z-2670-2026
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826REF/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, E21D32, E21F04, E21JFA, E21KHK1,028Z-2671-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.