Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label
Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II labeling error with no reported illnesses, injuries, or safety incidents. This is a minor labeling issue affecting device identification and traceability rather than direct patient safety hazard.
Plain-English summary
The Bubble Sensor (REF: 70105.5720) is an optional accessory to the CARDIOHELP-i extracorporeal life support system manufactured by Maquet Medical Systems USA. The device is being recalled due to an incorrect UDI Device Identifier (DI) printed on the product label.
The label on affected units displays an incorrect UDI DI of 04058863025148, when the correct UDI DI should be 04037691816432. This labeling error affects 274 units total, with 70 units distributed in the United States and 204 units distributed outside the United States. Affected units were distributed to healthcare facilities in Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Minnesota, Nebraska, Pennsylvania, Texas, Washington, and Wisconsin.
Healthcare facilities that received this device should verify their inventory using the provided serial numbers. If you have an affected unit, contact Maquet Medical Systems USA immediately.
The recalled product
- Product
- Bubble Sensor (REF: 70105.5720)
- Manufacturer
- Maquet Medical Systems USA
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: BS 3/8x3/32 L1.7
- Correct UDI DI: 04037691816432
- Incorrect UDI DI (as labeled): 04058863025148
Distribution
Related recalls
Same manufacturer · Maquet Medical Systems USA
See all →- HighCARDIOHELP-i System Recalled for Elevated Patient Leakage Current
FDA (Devices) · 2024-05-22
- HighFDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect
FDA (Devices) · 2024-02-21
- HighMedical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect
FDA (Devices) · 2024-02-21
- HighRotaFlow Centrifugal Pump sterile barrier defect FDA Class II recall
FDA (Devices) · 2024-02-14
- HighRotaFlow Centrifugal Pump Seal Defect Poses Infection Risk
FDA (Devices) · 2024-02-14
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHealthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
FDA (Devices) · 2026-10-21
- ModerateGore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
Similar recalls
- HighCARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings
FDA (Devices) · 2023-12-20
- ModerateBubble sensors recalled over connecting cables that can be damaged
FDA (Devices) · 2026-02-11
- ModerateStarling Monitor Devices Recalled for Incorrect Device Identification Labeling
FDA (Devices) · 2022-10-05
- HighCARDIOHELP-i System Recalled for Elevated Patient Leakage Current
FDA (Devices) · 2024-05-22
- ModerateCARDIOHELP-i Heart-Lung Support System not properly tested for leakage current
FDA (Devices) · 2023-12-27
- ModerateMaquet CARDIOHELP Base Unit Recalled for Display and Alarm Defects
FDA (Devices) · 2013-11-06