Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 3, 2014
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Thermedx LLC recalled The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate… - a moderate-severity action.
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate… was recalled by Thermedx LLC in September 3, 2014. Reason: A vendor changed the manufacturing process of a component used in the canister ring that may affect the perfo…. Check the official notice for the remedy. Verify recall #Z-2555-2014 with the FDA Devices before acting.
The recall
Thermedx LLC issued this moderate-severity FDA Devices recall-A vendor changed the manufacturing process of a component used in the canister ring that may affect the perfo….
- Moderate
- severity level
- 21 units
- affected scope
- Class II
- classification
- September 3, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2555-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2555-2014) was formally reported on September 3, 2014, with the manufacturer initiating the action on February 10, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Thermedx LLC is listed as the recalling firm, operating out of Solon, OH. Federal records list the affected scope as 21.
The documented reason for this recall is: A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canis… Distribution data in the federal record shows the product reached: Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.. 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
21
Related Recalls
6
3 from same agency
Product description
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
Reason for recall
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2555-2014 |
| Date reported | September 3, 2014 |
| Date initiated | February 10, 2014 |
| Recalling firm | Thermedx LLC |
| Firm location | Solon, OH |
| Affected scope | 21 |
| Distribution | Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL. |
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-2555-2014) 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? ▼
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.. Recalled by Thermedx LLC. Units affected: 21.
Why was this product recalled? ▼
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2014. Severity: Moderate. Recall number: Z-2555-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2555-2014) 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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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 September 3, 2014. 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.