PlainRecalls

Terumo Cardiovascular Systems Corp

13 recalls on record · Latest: Aug 1, 2018

Terumo Cardiovascular Systems Corp Recall Insight

Terumo Cardiovascular Systems Corp appears on 13 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.015% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Aug 1, 2018, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 13 entries, severity tagging shows 0 critical, 13 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 13 of 13 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (13). The date window on this page runs from Nov 12, 2014 to Aug 1, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Aug 1, 2018

Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass …

FDA Devices Moderate Apr 18, 2018

Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Ki…

FDA Devices Moderate Sep 7, 2016

Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use…

FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the des…

FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured a…

FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and custom…

FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and cust…

FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and custom…

FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and cust…

FDA Devices Moderate Jul 1, 2015

Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass proce…

FDA Devices Moderate Nov 12, 2014

Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is desi…

FDA Devices Moderate Nov 12, 2014

Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to…

FDA Devices Moderate Nov 12, 2014

Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardiople…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds