The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2495-2019·Announced 2019-09-18

Philips 5-Lead ECG Set Recalled Due to Connector Thickness Issue

Philips is recalling 5-Lead ECG sets because the connector thickness may prevent or impede I 2-Lead ECG measurements.

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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a functional defect (impeded measurement) rather than a direct physical injury risk.

Plain-English summary

Philips North America, LLC is recalling 280 boxes (5,600 leadsets) of Philips 5-Lead Set, Disposable, Bedside, AAMI (Model # 989803173131). The affected products are single-patient-use ECG lead sets used for bedside monitoring.

The recall is due to a manufacturing defect where the thickness of the connector to the trunk cable may be greater than specified. This issue may prevent or impede the performance of I 2-Lead ECG measurements. The affected lot codes are 03/18, 05/18, and 06/18.

The products were distributed worldwide, including in the US (KY, AZ, CA, UT, OH, NY, SC, CO, FL, IN, TX, ND, KS, GA), Canada, and Germany. No illnesses or injuries have been reported in the source text.

The recalled product

Product
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
Manufacturer
Philips North America, LLC
Category
Medical Device — ECG Lead Sets
Hazard

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 (2)

  • Lot codes: 03/18
  • 05/18 and 06/18

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Related recalls

Same manufacturer · Philips North America, LLC

See all →

Same hazard · functional defect

See all →

Similar recalls