Newborn monitor caps recalled over an incorrect sizing guide on labeling
SurePulse Medical is recalling the Surepulse VS Cap Medium because the labeling contains an incorrect sizing guide for the cap.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the record cites an incorrect sizing guide on labeling, with no device defect or stated consequence.
Plain-English summary
The Surepulse VS Cap Medium, REF SP-161-A1, a component of the VS Newborn Heart Rate Monitor, is being recalled by SurePulse Medical Ltd.
The reason given in the enforcement record is that the recall was retroactively reported, and that the labeling contains an incorrect sizing guide for the cap.
The record's quantity field reads 'N/A'. The recall covers DI number 05060550650020 with lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States in Connecticut and Texas, and to the United Kingdom, the Netherlands and other countries listed in the record. The FDA has classified the action as Class III, its least serious category.
The record cites an incorrect printed sizing guide rather than a device defect, and reports no injuries. Facilities should follow SurePulse's instructions.
The recalled product
- Product
- Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Manufacturer
- SUREPULSE MEDICAL LTD
Distribution
Part of a larger recall action
This product is one of 5 recalled by SUREPULSE MEDICAL LTD 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
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