Z-2597-2021Class II

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

Name: Z-2597-2021 OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control...
Creator: Hill-Rom, Inc.
Published: 2021-08-11
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2021-08-11 / Open, Classified

FDA source

Hill-Rom, Inc. began a recall of OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient... on 2021-08-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2597-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-11
Posted: 2021-09-30
Recalling firm: Hill-Rom Inc.
Product: 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
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
FDA root cause: Under Investigation by firm
Action: Hillrom issued URGENT Medical Device Correction letter dated August 11, 2021 by third party vendor via UPS mail/track the delivery to consignees. Letter states reason for recall, health risk and action to take: Hillrom is initiating this Medical Device Correction to all customers and will be correcting devices with an updated to the leveller. Actions being taken by Customer: Please share this Medical Device Correction with all potential users in your organization. Please ensure inspection of the device prior to use as stated in the device Instruction for Use (IFU). Complete the attached response form, acknowledging receipt, indicate the number of devices and return to [email protected] within one month
Quantity in commerce: 440 units
Distribution: 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.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2597-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2597-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2598-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2599-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2600-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2601-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)