OctoStretch with Stretch Leveller - The combination of this products allows the user to easily ad...

FDA Device Recall #Z-2597-2021 — Class II — August 11, 2021

Recall Summary

Recall Number Z-2597-2021
Classification Class II — Moderate risk
Date Initiated August 11, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hill-Rom, Inc.
Location Batesville, IN
Product Type Devices
Quantity 440 units

Product Description

OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056

Reason for Recall

Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates.

Lot / Code Information

N/A

Other Recalls from Hill-Rom, Inc.

Recall # Classification Product Date
Z-0783-2022 Class II (1)Traverse Rail Carrier E-System, wide 31017XX... Jan 14, 2022
Z-0639-2022 Class II Liko Mobile Lifts: Primarily intended for use i... Dec 23, 2021
Z-0640-2022 Class II Liko Mobile Lifts: Primarily intended for use i... Dec 23, 2021
Z-2600-2021 Class II LikoStretch 1900 Model Number: 3156051 - The co... Aug 11, 2021
Z-2599-2021 Class II Stretch Leveller Model Number: 3156200 - The co... Aug 11, 2021

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.