FlexoStretch Model Number: 3156057 — Class II medical device recall Z-2598-2021
Ongoing recall by Hill-Rom, Inc., reported 2021-10-06, distributed nationwide. Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position wh
| Recall number | Z-2598-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill-Rom, Inc., Batesville, IN, United States |
| Recall initiated | 2021-08-11 |
| Classified | 2021-09-30 |
| Reported by FDA | 2021-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BO, CA, CH, CN, CO, CR, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IN, IT, JO, JP, KW, LT, LV, MX, NL, NO, PL, PT, RS, SE, SK, TH, TR, TW |
| Quantity | 129 units |
| Model numbers | 3156057 |
Product
FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2598-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.