The Recall Desk

Hazard

Blood Flow Reduction recalls

14 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
14
Critical
0
Severe
12
Most recent
2023-03-22

Of the 14 blood flow reduction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (86%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all blood flow reduction recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–14 of 14

  • HighFDA (Devices)·Z-1245-2023·2023-03-22

    Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect

    Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.

    Product
    Fusion Bioline Vascular Graft, Part number M00201503046B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2021·2021-06-23

    Better-Bladder ECMO Device May Collapse, Reducing Blood Flow

    The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.

    Product
    The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1729-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1709-2018·2018-05-16

    Datascope recalls BEQ-TOP 5210 ECC Set custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.

    Product
    BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1715-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may cause balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1706-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling specific custom tubing kits because the Better Bladder device may allow air to enter, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1718-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 10 custom tubing kits because a seal defect may allow air to enter the housing, causing the balloon to collapse and reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1707-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling the Better Bladder device in some custom tubing kits because seal separation may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1712-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1728-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope Corporation is recalling BEQ-TOP 22301 Custom Tubing Kits because seal separation may allow air to enter the housing, causing the balloon to collapse and reducing blood flow.

    Product
    BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1714-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.

    Product
    BEQ-TOP 22701, Catalog No. 701050790
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1730-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1717-2018·2018-05-16

    Datascope Recalls Better Bladder Devices in Custom Tubing Kits

    Datascope is recalling specific custom tubing kits because the Better Bladder device may fail, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1711-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope is recalling Better Bladder devices in custom tubing kits because seal separation may cause balloon collapse and reduced ECMO blood flow.

    Product
    BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
    Category
    Medical Device
    Distribution
    13 states