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Lower risk Medical device recall · FDA · Published August 25, 2020

Terumo Air Sensor Recall: False Alarms from Wiring Issue

Terumo recalls air sensors for extracorporeal procedures due to wiring causing false alarms. Check serial numbers 20019-20020 for affected units.

🇺🇸 FDA recall #Z-2961-2020Medical deviceTerumo ›
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Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586
✎ GovInfoNow plain-language explainer

Terumo is recalling a specific air sensor used in heart-lung machines because a wiring issue causes false alarms during surgery. This could lead to unnecessary pauses in critical procedures if the alarm is triggered incorrectly. Read more at govinfonow.com/recall/64427-terumo-air-sensor-recall-false-alarms-from-wiring-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/64427-terumo-air-sensor-recall-false-alarms-from-wiring-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2961-2020

Cite this page

“Terumo Air Sensor Recall: False Alarms from Wiring Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64427-terumo-air-sensor-recall-false-alarms-from-wiring-issue. Based on FDA recall #Z-2961-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2961-2020%22&limit=1).

The FDA announced on August 25, 2020, that Terumo Cardiovascular Systems Corporation is recalling the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor due to a manufacturing defect. The hazard involves false air bubble alarms caused by an improperly installed wire connector.

How to tell if you have it

  • Brand: Terumo
  • Product: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32
  • Catalog Number: 5791
  • Serial Numbers: 20019, 20020
  • Quantity: 2 units

The hazard

Internal testing revealed that a crimped wire was placed into the air bubble detector sensor connector backwards. This prevents the wire from locking correctly, which may result in false air bubble alarms.

Context

GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Recent brand recalls include the May 28, 2025 Terumo CDI OneView BPM Probe Recall for temperature inaccuracy risk and the March 3, 2025 Terumo CDI OneView Hematocrit Probe recall for dashed SO2 values triggering false alarms. Other recent recalls of similar products include the June 30, 2026 Getinge SERVO-U/N Ventilator Sensor Module Recall and the May 21, 2026 Hillrom VOLARA System Circuit Kit Recall.

How to tell if you have this one

Check for serial numbers 20019 or 20020 on the sensor. The product is used with Terumo and Sarns air detection systems during heart-lung procedures.

  • Brand
    Terumo
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2959-2020Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.; UDI: 00886799000038; Serial Numbers: 20288 20289 20290 20291 20292 20293 20294 20295 20296 20299 20300 20301 20302 20306 20307 20308 20309 20310 20312 20317 20318 20320 20321 20322 20323 20324 20326 20328 20329 20331 20332 20334 20338 20339 20341 20342 20343 20344 20345 20346 20347 20348 20349 20350 20351 20352 20358 20365 20368 20373 20374 20375 20381 20382 20383 20384 20385 20387 20388 20392 20393 20395 20396 20397 20398 20399 20401 20402 20403 20404 20405 20408 20410 20411 20412 20555 20556 20557 20558 20559 20560 20561 20562 20563 20564 20565 20566 20567 20568 20569 20570 20571 20572 20573 20574 20575 20576 20577 20578 20579100
Z-2960-2020Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.; UDI: 00886799000045; Serial Numbers: 20230 20263 202653
Z-2961-2020Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.; UDI: 00886799000052; Serial Numbers: 20019 200202
Based on the official FDA remedy

What to do — step by step

  1. Check Sensor Serial Number

    Look for serial numbers 20019 or 20020 on the sensor.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Aug 25, 202012. FDA classified it Class II: Sep 11, 202023. Published in FDA’s Enforcement Report: Sep 23, 202034. FDA terminated the recall: Jan 29, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-2961-2020 (August 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2961-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA