Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 19, 2014
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft …
Smith & Nephew Inc. recalled Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dres… — a moderate-severity action.
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dres… was recalled by Smith & Nephew Inc. in March 19, 2014. Reason: Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blo…. Check the official notice for the remedy. Verify recall #Z-1159-2014 with the FDA Devices before acting.
The recall
Smith & Nephew Inc. issued this moderate-severity FDA Devices recall — Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blo….
- Moderate
- severity level
- Class II
- classification
- March 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1159-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1159-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on January 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Smith & Nephew Inc. is listed as the recalling firm, operating out of Saint Petersburg, FL. Federal records list the affected scope as 15,754 indivdual units.
The documented reason for this recall is: Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improp… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries D…. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
15,754 indivdual units
Related Recalls
6
6 from same agency
Product description
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Reason for recall
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1159-2014 |
| Date reported | March 19, 2014 |
| Date initiated | January 9, 2014 |
| Recalling firm | Smith & Nephew Inc. |
| Firm location | Saint Petersburg, FL |
| Affected scope | 15,754 indivdual units |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argen… |
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-1159-2014) 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? ▼
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps). Recalled by Smith & Nephew Inc.. Units affected: 15,754 indivdual units.
Why was this product recalled? ▼
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1159-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1159-2014) 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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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 19, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.