Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 10, 2012
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, chron
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 displa…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Accuro Medical Product LLC recalled Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Produ… - a moderate-severity action.
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Produ… was recalled by Accuro Medical Product LLC in October 10, 2012. Reason: Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without …. Check the official notice for the remedy. Verify recall #Z-0009-2013 with the FDA Devices before acting.
The recall
Accuro Medical Product LLC issued this moderate-severity FDA Devices recall-Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without ….
- Moderate
- severity level
- 919 units
- affected scope
- Class II
- classification
- October 10, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0009-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0009-2013) was formally reported on October 10, 2012, with the manufacturer initiating the action on August 31, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Accuro Medical Product LLC is listed as the recalling firm, operating out of Downers Grove, IL. Federal records list the affected scope as 919 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and country of: Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
919 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0009-2013 |
| Date reported | October 10, 2012 |
| Date initiated | August 31, 2012 |
| Recalling firm | Accuro Medical Product LLC |
| Firm location | Downers Grove, IL |
| Affected scope | 919 units |
| Distribution | Worldwide distribution: USA (nationwide) and country of: Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0009-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accuro Medical Product LLC. Units affected: 919 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2012. Severity: Moderate. Recall number: Z-0009-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and country of: Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0009-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 10, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.