Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump — Class II medical device recall Z-0009-2013
Terminated recall by Accuro Medical Product LLC, reported 2012-10-10, distributed nationwide. Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without n
| Recall number | Z-0009-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuro Medical Product LLC, Downers Grove, IL, United States |
| Recall initiated | 2012-08-31 |
| Classified | 2012-10-04 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 919 units |
| Reason classes | device malfunction |
| Serial numbers | E000146 |
| Model numbers | 84635400181, 84635400182 |
Product
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Reason for recall
Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
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-0009-2013. 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.