Stop using nowMedical device recall · FDA · Published February 8, 2018
Medtronic BIO CAL Temperature Controller Models 370/370I: Discontinue Use Due to Cleaning
Medtronic recalls BIO CAL(R) Temperature Controllers (Models 370 and 370I) due to inability to develop a safe cleaning protocol. Affected units must be discontinued and disposed of immediately.
Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.
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Contact the company
📍Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088
“Medtronic BIO CAL Temperature Controller Models 370/370I: Discontinue Use Due to Cleaning.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72020-medtronic-bio-cal-temperature-controller-models-370-370i-discontinue-use. Based on FDA recall #Z-0900-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2018%22&limit=1).
The FDA announced on Feb. 8, 2018, that Medtronic Perfusion Systems is recalling BIO CAL Temperature Controllers due to an inability to develop a cleaning protocol satisfying industry concerns. The agency said users should discontinue use and dispose of the devices immediately.
How to tell if you have it
BIO CAL Temperature Controller, Model 370
BIO CAL Temperature Controller, Model 370I
The hazard
Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Medtronic EOPA Arterial Cannula Recall (June 24, 2026), Medtronic Pediatric Cannula Recall (May 25, 2026), and Medtronic Octopus Evolution AS Tissue Stabilizer Model TS2500 Recall (May 12, 2026). Other recent recalls of similar products include Medline Recalls Control Syringes and Manifold Kits Due to Regulatory Clearance Rescinded (Feb. 25, 2026), Medline PICC Tray DYNJ41648A Recall (Feb. 25, 2026), and Medline D&C Pack Kits: Rescinded Regulatory Clearances (Feb. 25, 2026).
How to tell if you have this one
The recalled units are Models 370 and 370I with specific serial numbers listed in the record. These devices are used for controlling patient blood temperature during heart surgery.
Brand
Medtronic Perfusion Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the BIO CAL(R) Temperature Controller and dispose of it safely.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0900-2018 (February 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0900-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.