Z-1739-2025Class II

Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility...

Name: Z-1739-2025 Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility...
Creator: Wandercraft Sas
Published: 2025-04-03
License: https://open.fda.gov/license/

Wandercraft / initiated 2025-04-03 / Open, Classified

FDA source

WANDERCRAFT SAS began a recall of Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions... on 2025-04-03. FDA classified it as Class II and gives the reason as "Potential for exoskeleton to lose lateral balance and cause patient to fall". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1739-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-03
Posted: 2025-05-08
Recalling firm: Wandercraft
Product: Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
Product code: PHL Powered Exoskeleton
Reason for recall: Potential for exoskeleton to lose lateral balance and cause patient to fall.
FDA root cause: Use error
Action: An URGENT SAFETY NOTICE dated 4/3/25 was mailed to consignees. The letter notifies consignees that WANDERCRAFT will be reinforcing their training program for the Atalante X and providing additional instructions by 5/1/25. Until the additional instructions can be provided, users are being instructed to only have certified Atalante X operators maintain the stability of the exoskeleton at all times by keeping at least one hand on the handles throughout the session. Consignees are to share the recall notification with users at their facility and retained for awareness.
Quantity in commerce: 3
Distribution: Domestic: PA & NY.
Product codes and lots: UDI: (01)3665965000129(21)V5_ABP(11)AA06JJ, (01)3665965000129(21)V5_ACH(11)AA09JJ, (01)3665965000129(21)V5_ADO(11)AA02JJ. No model or serial number.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1739-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1739-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-08

Product code PHL

K221859Class IIAtalanteWandercraft SAS / cleared 2022-12-29

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)