Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SUREPULSE MEDICAL LTD or your healthcare provider for instructions. Notification method: N/A
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recalled product is the Extra Large VS Cap, REF: SP-163-A1, part of the VS Newborn Heart Rate Monitor. The specific model numbers include DI Number: 05060550650044 along with various lot numbers from 13816 to 13840. The product was distributed worldwide, primarily in Connecticut and Texas.
The recall was initiated due to a labeling error that contains an incorrect sizing guide for the cap. This could lead to improper fitting and potentially compromise the functionality of the device.
No specific incidents or injuries have been reported related to this recall. The classification level is considered Class III, indicating a low risk of serious injury.
Stop using the VS Cap immediately. Contact Surepulse Medical Ltd or your healthcare provider for further instructions.
Consumers can contact Surepulse Medical Ltd for additional details regarding this recall. Visit the FDA link for more information: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1360-2026.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.