Maquet Getinge-BEQ-TOP 5502 ECC Pack Recall for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of ECC packs because a design feature may prevent proper sterilization, potentially compromising sterility.
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 is classified as FDA Class II. The hazard involves a potential failure of sterilization assurance (SAL) for a medical device used in extracorporeal circulation, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 5502 ECC Packs (Material: 701051791). The affected products are Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves batch numbers 3000043651, 3000047320, 3000062721, 3000064716, and 3000072309. The products were distributed nationwide.
The recall was initiated because the closed stopcock/non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which may compromise the sterility of the device.
Healthcare facilities and consumers who have these specific batches should stop using the products and contact Maquet Cardiovascular, LLC for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
- 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: 3000043651 3000047320 3000062721 3000064716 3000072309
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 assurance failure
See all →- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
- SevereTirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2025-07-02
- HighOmnicell IVX Station Reconstitution Transfer Sets Recall
FDA (Devices) · 2025-04-16
- HighCompounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance
FDA (Drugs) · 2025-04-02
- HighHYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03