Maquet Getinge Pediatric Pack Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific pediatric packs for extracorporeal circulation because a design issue may prevent proper sterilization of the stopcock ports.
What this means for you
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 the sterility of the product cannot be assured, creating a risk of infection or harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-T 8069 Pediatric Pack (Material: 701064965) for extracorporeal circulation. The recall involves batch numbers 3000046123 and 3000059176, which were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
Healthcare facilities and users should stop using the affected products and contact Maquet Cardiovascular for further instructions on handling the recalled items.
The recalled product
- Product
- Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
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: 3000046123 3000059176
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 · infection risk
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighMedline Micro-Kill Bleach Germicidal Wipes Recalled for Reduced Concentration
FDA (Devices) · 2026-08-19
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29