Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 7, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Smisson-Cartledge Biomedical, LLC recalled ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCo… — a critical-severity action.
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCo… was recalled by Smisson-Cartledge Biomedical, LLC in April 7, 2021. Reason: Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminu…. Check the official notice for the remedy. Verify recall #Z-1258-2021 with the FDA Devices before acting.
The recall
Smisson-Cartledge Biomedical, LLC issued this critical-severity FDA Devices recall — Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminu….
- Critical
- severity level
- 18K units
- affected scope
- Class I
- classification
- April 7, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1258-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1258-2021) was formally reported on April 7, 2021, with the manufacturer initiating the action on February 18, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Smisson-Cartledge Biomedical, LLC is listed as the recalling firm, operating out of Macon, GA. Federal records list the affected scope as 18482 devices.
The documented reason for this recall is: Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. Distribution data in the federal record shows the product reached: Nationwide Distribution in US and international via 2 US distributors (VA and GA). 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 high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
18482 devices
Related Recalls
6
6 from same agency
Product description
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
Reason for recall
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1258-2021 |
| Date reported | April 7, 2021 |
| Date initiated | February 18, 2021 |
| Recalling firm | Smisson-Cartledge Biomedical, LLC |
| Firm location | Macon, GA |
| Affected scope | 18482 devices |
| Distribution | Nationwide Distribution in US and international via 2 US distributors (VA and GA) |
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-1258-2021) 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.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. 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? ▼
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures. Recalled by Smisson-Cartledge Biomedical, LLC. Units affected: 18482 devices.
Why was this product recalled? ▼
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 7, 2021. Severity: Critical. Recall number: Z-1258-2021.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution in US and international via 2 US distributors (VA and GA).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1258-2021) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 7, 2021.
- 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.