Maquet recalls Bubble Sensor (REF: 70105.5720) with incorrect UDI Device Identifier on labels. Affected units have specific serial numbers and correct identifier 04037691816432.
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
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Contact the company
📍Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094
“Maquet Bubble Sensor Recall: Incorrect UDI Device Identifier Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56453-maquet-bubble-sensor-recall-incorrect-udi-device-identifier-risk. Based on FDA recall #Z-1053-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1053-2024%22&limit=1).
Maquet Medical Systems USA recalled Bubble Sensor units because they include an incorrect UDI Device Identifier on the label, the FDA said on Dec. 28, 2023. The recall affects 70 units distributed in Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Minnesota, Nebraska, Pennsylvania, Texas, Washington and Wisconsin.
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier provided with the label attached to the device.
Context
GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Other recent recalls include a Maquet Cardiohelp-i System recall for excessive patient leakage current risk (April 15, 2024) and a Maquet BEQ-HLS 7050 recall for compromised sterile barrier risk (Jan. 16, 2024). Other recent recalls of similar products include a Maquet Bubble Sensor recall for cable durability issues (Jan. 9, 2026), an Abiomed Impella RP recall for sensor malfunction risk (Jan. 27, 2026) and a Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray recall for erroneous safety indicator risk (Nov. 6, 2025).
How to tell if you have this one
Check for the model BS 3/8x3/32 L1.7 with serial numbers listed in the recall (e.g., 90041799, 90041816). The incorrect UDI DI on the label is 04058863025148 instead of the correct 04037691816432.
Brand
Maquet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for the UDI Device Identifier on the label; the incorrect code is 04058863025148.
Verify Serial Numbers
Affected units have specific serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 13 states.
Listed by the agency
Not listed
FDA distribution: “AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-1053-2024 (December 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1053-2024 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.