GE Healthcare Recalls Fetal Scalp Electrodes Due to Packaging Seal Issues
Vital Signs Devices is recalling 126 cases of Corometrics Qwik Connect Plus Spiral Electrodes because 30 units had incomplete package seals and missing lot numbers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II. The hazard involves packaging integrity (incomplete seal) and labeling (missing lot number) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Vital Signs Devices, a GE Healthcare Company, is recalling 126 cases (50 pouches per case) of Corometrics Qwik Connect Plus Spiral Electrodes, Model #7000AA0. The recall is due to the discovery that thirty fetal scalp electrodes had an incomplete package seal and lacked the printed lot number stamped on during sealing.
The affected product is a fetal scalp circular (spiral) electrode and applicator used to obtain a fetal electrocardiogram during labor and delivery. The recall covers Lot #S03123. The products were distributed worldwide, including nationwide in the United States (specifically AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC, TX, WA, and WY) and in Australia and Canada.
Healthcare providers and consumers should stop using the affected devices and contact Vital Signs Devices for further instructions.
The recalled product
- Product
- Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
- Manufacturer
- Vital Signs Devices, a GE Healthcare Company
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 (1)
- Lot #S03123 Model #7000AA0
Distribution
Related recalls
Same manufacturer · Vital Signs Devices, a GE Healthcare Company
See all →- HighGE Healthcare Recalls Disposable Temperature Probes Due to Safety Concerns
FDA (Devices) · 2013-08-21
- HighGE Healthcare Recalls enFlow IV Fluid Warmer Straps for Biocompatibility Issues
FDA (Devices) · 2012-07-18
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- SeverePhilips Fetal Spiral Electrode Recall Due to Metal Tip Breakage Risk
FDA (Devices) · 2019-05-08
- ModeratePhysio-Control Recalls Infant Defibrillation Electrodes Due to Packaging Seal Issues
FDA (Devices) · 2020-06-17
- ModeratePhysio-Control Recalls Infant Child Starter Kits Due to Packaging Seal Issues
FDA (Devices) · 2020-06-17
- HighCook Lead Clipper Cardiac Device Sterility Recall Due to Packaging Defect
FDA (Devices) · 2023-09-13
- SeverePacific Medical Fetal Transducers Recalled for Lack of Regulatory Clearance
FDA (Devices) · 2020-02-12
- HighOphthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise
FDA (Devices) · 2025-01-08