Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered...

FDA Device Recall #Z-1935-2020 — Class II — April 7, 2020

Recall Summary

Recall Number Z-1935-2020
Classification Class II — Moderate risk
Date Initiated April 7, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Medical Division of Stryker Corporation
Location Portage, MI
Product Type Devices
Quantity 34 units

Product Description

Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).

Reason for Recall

Ambulance Cots may not meet crash test standard BS EN 1789

Distribution Pattern

Foreign: UK

Lot / Code Information

Serial Numbers: 1909003700051 1909003700052 1909003700055 1909003700056 1909003700057 1909003700058 1909003700059 1909003700060 1909003700061 1909003700062 1909003700065 1909003700066 1909003700067 1909003700068 1909003700069 1909003700070 1909003700072 1909003700073 1909003700074 1909003700075 1909003700076 1909003700077 1909003700078 1909003700079 1909003700080 1909003700081 1909003700082 1909003700083 1909003700084 1909003700085 1909003700086 1909003700087 1909003700088 1909003700090

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.