CLASS II ONGOING Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
LikoStretch Mod 600 IC recalled by Hill-Rom
Hill-Rom is recalling LikoStretch Mod 600 IC, distributed nationwide in the US. The recall was initiated on 11 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2601-2021
- FDA event ID
- 88548
- Recalling firm
- Hill-Rom, Batesville, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Aug 2021
- FDA classified
- 30 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Aug 2021 | Recall initiated by company | |
| 30 Sep 2021 | Classified by FDA | +50 days |
| 6 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoDelawareIllinoisMaineMichiganMissouriMississippiNew JerseyOhioPennsylvaniaVirginiaWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
N/A LikoStretch Mod 600 IC, Wide 3156065B UDI: 0887761GMN000036U9
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 88548| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | LikoStretch 1900 Model Number: 3156051 - The combination of this recalled | Hill-Rom | Other | Nationwide | |
| CLASS II | Stretch Leveller recalled by Hill-Rom | Hill-Rom | Other | Nationwide | |
| CLASS II | FlexoStretch Model Number recalled by Hill-Rom | Hill-Rom | Other | Nationwide | |
| CLASS II | OctoStretch with Stretch Leveller recalled by Hill-Rom | Hill-Rom | Other | Nationwide |
More recalls from Hill-Rom
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Traverse Rail Carrier E-System recalled by Hill-Rom | Hill-Rom | Other | Nationwide |
| Device | CLASS II | Liko Mobile Lifts: Primarily intended for use recalled by Hill-Rom | Hill-Rom | Other | Nationwide |
| Device | CLASS II | Liko Mobile Lifts: Primarily intended for use recalled by Hill-Rom | Hill-Rom | Other | Nationwide |
| Device | CLASS II | These are communication systems, labeled as recalled by Hill-Rom | Hill-Rom | Device Malfunction | Nationwide |
| Device | CLASS II | OctoStretch with Stretch Leveller recalled by Hill-Rom | Hill-Rom | Other | Nationwide |
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