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Handi-Move Sling
Handi-Move · Model 3461XL 00000001 · UDI-DI 05404016611376
10
510(k) clearances
15,182
Adverse events (428 deaths)
142
Recalls
205
Facilities
Description
Sling 3461XL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-14 | Baxter Healthcare Corporation | Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quic |
| 2026-03-10 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss |
| 2025-12-18 | Community Products, LLC | Potential for fraying on the body support strap. |
| 2025-12-18 | Community Products, LLC | Potential for fraying on the body support strap. |
| 2025-12-18 | Community Products, LLC | Potential for fraying on the body support strap. |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
| 2025-05-30 | Baxter Healthcare Corporation | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury fro |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.