Use caution Medical device recall · FDA · Published January 10, 2020

Terumo Roller Pump Recall: Noise Risk from Pump Shaft Failure

Terumo recalls specific roller pumps that may fail due to noise, risking pump stoppage during blood circulation procedures. Affected units have serial numbers starting with 880559-882813 and 885541-885543.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1111-2020Medical device Terumo ›

Use caution until it’s fixed

These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.

Take action

Contact the company

Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586

✎ GovInfoNow plain-language explainer

Terumo is recalling certain roller pumps used in blood circulation procedures because faulty shafts can cause noise and pump failure. This could stop blood flow during critical medical procedures if not fixed. Read more at govinfonow.com/recall/66115-terumo-roller-pump-recall-noise-risk-from-pump-shaft-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/66115-terumo-roller-pump-recall-noise-risk-from-pump-shaft-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1111-2020

Cite this page

“Terumo Roller Pump Recall: Noise Risk from Pump Shaft Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66115-terumo-roller-pump-recall-noise-risk-from-pump-shaft-failure. Based on FDA recall #Z-1111-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1111-2020%22&limit=1).

The FDA announced on Jan. 10, 2020, that Terumo Cardiovascular Systems Corporation voluntarily recalled the Terumo Advanced Perfusion Assembly Pump Guts due to potential pump shaft failure. The agency classified the recall as Class II.

How to tell if you have it

Brand: Terumo
Product: Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch
Catalog Number: 801805
Serial Numbers: 880559, 880560, 882808, 882809, 882810, 882811, 882812, 882813, 885541, 885542, 885543

The hazard

The roller pumps were assembled with pump shafts that may fail at the thread where a locknut is installed. Prolonged use in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.

Context

GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Other recent recalls of similar products include Fresenius Kabi LVP-0004 Infusion Pump Recall (Feb. 4, 2026), B. Braun Medical Spinal Epidural Pump Model 530184 Recall (Jan. 29, 2026), and Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (Aug. 10, 2026).

How to tell if you have this one

Check for serial numbers starting with 880559, 880560, 882808-882813, or 885541-885543. These pumps are used for blood circulation procedures and are labeled for up to 6 hours of operation.

Brand
Terumo
Category
Medical device

FDA recall event · 4 products

All 4 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 in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.

Recall number	Product, codes & lots	Quantity
Z-1108-2020	Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.; UDI: 00886799000533; Serial Numbers: 6860 6861 6862 6863 6864 6865 6876 6877 6885 6910 6911 6912 6913 6934 6935 6936 6937 6938 6939 6940 6941 6942 6943 6944 6945 6946 6947 6948 6949 6950 6951 6952 6953	33
Z-1109-2020	Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.; UDI: 00886799000533; Serial Numbers: 7919 8165 8166 8167 8168 8169 8170 8173 8174 8175 8176 8179 8180 8181 8182 8183 8184 8185 8186 8187 8188 8189 8190 8191 8192 8193 8194 8195 8196 8197 8198 8199 8200 8201 8202 8203 8204 8205 8206 8207 8208 8209 8210 8211 8212 8213 8214 8215 8216 8217 8218 8219 8220 8221 8222 8223 8224 8225 8226 8227 8228 8229 8230 8231 8232 8233 8234 8235 8236 8237 8241 8242 8243 8244 8251 8253 8254 8255 8256 8257 8258 8259 8260 8261 8262 8263 8264 8265 8266 8267 8268 8269 8270 8271 8273 8274 8275 8276 8280 8307 8308 8309 8310 8311 8313 8335	106
Z-1110-2020	Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.; Serial Numbers: 882298 882299 882300 882752 882753 882794 882795 882796 882797 882798 882799 885547 885548 885549 885550 885553	16
Z-1111-2020	Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.; Serial Numbers: 880559 880560 882808 882809 882810 882811 882812 882813 885541 885542 885543	11

Based on the official FDA remedy

What to do — step by step

Check Pump Serial Number
Identify the serial number on the pump to see if it matches the affected range: 880559, 880560, 882808-882813, or 885541-885543.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 7 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York, Texas.

Recall timeline

FDA terminated this recall 4 months after the firm started it.

Jan 10, 2020Firm started the recall
Feb 7, 2020FDA classified it Class II
Feb 19, 2020Published in FDA’s Enforcement Report
May 12, 2020FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Terumo recalls

Link to this recall

<a href="https://govinfonow.com/recall/66115-terumo-roller-pump-recall-noise-risk-from-pump-shaft-failure">Terumo Roller Pump Recall: Noise Risk from Pump Shaft Failure (GovInfoNow)</a>

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-1111-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1111-2020 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.