BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a…
Medical device recall Z-0900-2018. Published in FDA’s Enforcement Report on Mar 14, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 1980 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
1980 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(a) Model 370, Serial Numbers: 0101 0211 0322 0432 0543 0653 0764 AK0874 AK0985 AK1095 AK1206 AK1316 AK1427 AK1537 0102 0212 0323 0433 0544 0654 0765 AK0875 AK0986 AK1096 AK1207 AK1317 AK1428 AK1538 0103 0213 0324 0434 0545 0655 0766…
Every code shown here, 1,998 characters
(a) Model 370, Serial Numbers: 0101 0211 0322 0432 0543 0653 0764 AK0874 AK0985 AK1095 AK1206 AK1316 AK1427 AK1537 0102 0212 0323 0433 0544 0654 0765 AK0875 AK0986 AK1096 AK1207 AK1317 AK1428 AK1538 0103 0213 0324 0434 0545 0655 0766 AK0876 AK0987 AK1097 AK1208 AK1318 AK1429 AK1539 0104 0214 0325 0435 0546 0656 0767 AK0877 AK0988 AK1098 AK1209 AK1319 AK1430 AK1540 0105 0215 0326 0436 0547 0657 0768 AK0878 AK0989 AK1099 AK1210 AK1320 AK1431 AK1541 0106 0216 0327 0437 0548 0658 0769 AK0879 AK0990 AK1100 AK1211 AK1321 AK1432 AK1542 0107 0217 0328 0438 0549 0659 0770 AK0880 AK0991 AK1101 AK1212 AK1322 AK1433 AK1543 0108 0218 0329 0439 0550 0660 0771 AK0881 AK0992 AK1102 AK1213 AK1323 AK1434 AK1544 0109 0219 0330 0440 0551 0661 0772 AK0882 AK0993 AK1103 AK1214 AK1324 AK1435 AK1545 0110 0220 0331 0441 0552 0662 0773 AK0883 AK0994 AK1104 AK1215 AK1325 AK1436 AK1546 0111 0221 0332 0442 0553 0663 0774 AK0884 AK0995 AK1105 AK1216 AK1326 AK1437 AK1547 0112 0222 0333 0443 0554 0664 0775 AK0885 AK0996 AK1106 AK1217 AK1327 AK1438 AK1548 0113 0223 0334 0444 0555 0665 0776 AK0886 AK0997 AK1107 AK1218 AK1328 AK1439 AK1549 0114 0224 0335 0445 0556 0666 0777 AK0887 AK0998 AK1108 AK1219 AK1329 AK1440 AK1550 0115 0225 0336 0446 0557 0667 0778 AK0888 AK0999 AK1109 AK1220 AK1330 AK1441 AK1551 0116 0226 0337 0447 0558 0668 0779 AK0889 AK1000 AK1110 AK1221 AK1331 AK1442 AK1552 0117 0227 0338 0448 0559 0669 0780 AK0890 AK1001 AK1111 AK1222 AK1332 AK1443 AK1553 0118 0228 0339 0449 0560 0670 0781 AK0891 AK1002 AK1112 AK1223 AK1333 AK1444 AK1554 0119 0229 0340 0450 0561 0671 0782 AK0892 AK1003 AK1113 AK1224 AK1334 AK1445 AK1555 0120 0230 0341 0451 0562 0672 0783 AK0893 AK1004 AK1114 AK1225 AK1335 AK1446 AK1556 0121 0231 0342 0452 0563 0673 0784 AK0894 AK1005 AK1115 AK1226 AK1336 AK1447 AK1557 0122 0232 0343 0453 0564 0674 0785 AK0895 AK1006 AK1116 AK1227 AK1337 AK1448 AK1558 0123 0233 0344 0454 0565 0675 0786 AK0896 AK1007 AK1117 AK1228 AK1338 AK1449 AK1559 0124 0234 0345 0455 0566 0676 0787…
FDA’s list runs to 12,725 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 8, 2018.
- FDA classified it on Mar 6, 2018.
- FDA’s Enforcement Report published it on Mar 14, 2018.
- FDA terminated it on Aug 6, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Perfusion Systems, of Brooklyn Park, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 12,725 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.