Agency classClass IIOur severity:High FDA (Devices)·Z-2217-2021·Announced 2021-08-18

TruRize Clinical Chair distributed to home users who may misuse it

Stryker's TruRize Clinical Chair was distributed to residential customers despite being designed for healthcare facility use only. Home users may not understand safety instructions intended for trained professionals.

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 an FDA Class II recall of a risk-of-harm product. The device was designed for trained healthcare professionals but was distributed to residential users who may not understand critical safety instructions, creating potential for misuse and injury. No illnesses or injuries have been reported to date.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling the TruRize Clinical Chair, Model 3333 (Part # 3333000000), which was distributed to residential customers.

The TruRize Clinical Chair is a medical device designed specifically for use in healthcare facilities to position patients in various positions (upright, seated, recline, supine, and trendelenburg). The device's labeling correctly identifies its intended use environment. However, residential users who received this device may not be aware of or fully understand the safety instructions and usage guidelines that were written for trained healthcare professionals.

This product was distributed worldwide, including throughout the United States, Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.

If you own a TruRize Clinical Chair, contact Stryker Medical Division to determine whether your device should remain in use or be returned.

The recalled product

Product: TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Clinical furniture
Hazard: improper-use
wrong-environment
Affected units: 1

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: 2017000300284 UDI: 07613327322569

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 →

Same manufacturer · Stryker Medical Division of Stryker Corporation

See all →

Moderate
Stryker Cub pediatric cribs sold in USA missing two warning labels
FDA (Devices) · 2026-03-25
Moderate
Bariatric hospital beds recalled because they are not tested with certain mattresses
FDA (Devices) · 2025-12-17
Moderate
Hospital mattresses recalled because they are not tested with certain beds
FDA (Devices) · 2025-12-17
High
ProCurity patient beds recalled for electrical safety testing defects
FDA (Devices) · 2023-12-13
High
ProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing
FDA (Devices) · 2023-12-13

Same hazard · improper use