Maquet Getinge Quadrox iD Pack Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Quadrox iD Packs because a design feature may prevent proper sterilization, potentially compromising sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be assured, posing a risk of infection (harm) without reported injuries, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge BEQ-TOP 27700 Quadrox iD Packs (Material: 701054389R02) with batch numbers 3000049066 and 3000053533. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration during the sterilization process.
The agency notes that this configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which could compromise the sterility of the device.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected units and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
- Manufacturer
- Maquet Cardiovascular, LLC
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 (1)
- Batch Numbers: 3000049066 3000053533
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 183 products in this recall →Related recalls
Same manufacturer · Maquet Cardiovascular, LLC
See all →- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighVessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
FDA (Devices) · 2025-10-01
- HighHeartstring III seal systems recalled over failures to load, deploy and seal
FDA (Devices) · 2025-09-24
- HighHeartstring III 4.3 mm seal systems recalled over loading and deployment failures
FDA (Devices) · 2025-09-24
- HighHeartstring III 3.8 mm seal systems recalled over three identified failure modes
FDA (Devices) · 2025-09-24
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighGetinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns
FDA (Devices) · 2019-12-18
- HighMaquet QUADROX-i oxygenators recalled for potential endotoxin exposure
FDA (Devices) · 2016-04-20
- HighMaquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier
FDA (Devices) · 2023-06-07
- HighMaquet QUADROX-iR Cardiopulmonary Bypass Device Recalled for Packaging Damage
FDA (Devices) · 2023-06-07
- HighQUADROX-i Adult Oxygenator Recalled for Packaging Defects Compromising Sterility
FDA (Devices) · 2023-06-07
- HighQUADROX-i Small Adult Oxygenator Recall Due to Sterile Packaging Defects
FDA (Devices) · 2023-06-07