Small newborn monitor caps recalled over an incorrect sizing guide
SurePulse Medical is recalling the Surepulse VS Cap Small because the labeling contains an incorrect sizing guide for the cap.
What this means for you
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 Small, REF SP-160-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 05060550650013 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 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 Small REF: SP-160-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
Same manufacturer · SUREPULSE MEDICAL LTD
See all →- LowLarge newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
- LowExtra large newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
- LowNewborn monitor caps recalled over an incorrect sizing guide on labeling
FDA (Devices) · 2026-02-18
- LowExtra small newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
Same hazard · labeling
See all →- ModerateSaccharin sweetener packets recalled over undeclared aspartame in the product
FDA (Food) · 2026-02-18
- ModerateCuban mojo marinade recalled over undeclared quinine in the product
FDA (Food) · 2026-02-11
- ModerateOrganic sumac recalled over a no salt claim on salted product
FDA (Food) · 2026-02-11