ArjoHuntleigh Flowtron ACS900 — Class II medical device recall Z-2714-2017

Terminated recall by Arjo, Inc. dba ArjoHuntleigh, reported 2017-07-19, distributed nationwide. Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating a

Recall number	`Z-2714-2017`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Arjo, Inc. dba ArjoHuntleigh, Addison, IL, United States
Recall initiated	2017-06-14
Classified	2017-07-11
Reported by FDA	2017-07-19
Terminated	2022-08-12
Distributed	Nationwide (US)
Countries outside the US	AE, AT, AU, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DK, EC, ES, FR, GB, GR, HU, IE, IL, IN, IT, JO, JP, KW, LB, MX, MY, NL, NO, NZ, OM, PK, PL, PY, QA, SA, SE, SG, ZA
Quantity	40,675 units
Model numbers	`526000-01`, `526000-01P`, `526000-02`, `526000-02P`

Product

ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.

Reason for recall

Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

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-2714-2017. 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.