Agency classClass IIOur severity:High FDA (Devices)·Z-2212-2021·Announced 2021-08-18

Medical device designed for healthcare professionals distributed to untrained home users

Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II medical device intended for treatment of pressure injuries. While no illnesses or injuries have been reported, the device is being used outside its intended healthcare setting by untrained home users, creating a risk-of-harm situation where improper use could result in inadequate treatment or worsening of pressure injuries.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling the ComfortGel, Model Number 2850, a medical device designed to prevent and treat pressure injuries at all stages. The device was intended for use in healthcare facilities by trained professionals.

The ComfortGel was distributed to residential customers and may be in use in home environments. Although the product's labeling correctly identifies the healthcare facility as the intended use environment, home users may not be fully aware of or understand the instructions written for healthcare professionals. This mismatch between the intended user population and actual users creates a potential risk of improper use and inadequate treatment of pressure injuries.

The device has been distributed worldwide, including throughout the United States and internationally to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.

The recalled product

Product: ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Wound Care / Pressure Injury Treatment
Hazard: improper-use
insufficient-training
Affected units: 3

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)

Serial Numbers: 20170928500311838 UDI: 07613327277852 07613327277937

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Stryker Medical Division of Stryker Corporation 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 19 products in this recall →

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