Terumo Cardiovascular Procedure Kit Recalled for Incorrect Customer Notification Label
Terumo is recalling 37 units of Cardiovascular Procedure Kits in California due to an incorrect customer notification label applied to the Tyvek lid.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is an incorrect label and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 37 units of the Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE (Catalog Number: 73431). The recall is limited to Lot Number RA-27, which was distributed in California.
The recall was initiated because an incorrect customer notification label was applied to the Tyvek lid of the affected kits. The source text does not report any illnesses, injuries, or deaths associated with this labeling error.
Healthcare providers and consumers who have this specific lot of the product should stop using it and contact Terumo Cardiovascular Systems Corp for instructions on how to return the product.
The recalled product
- Product
- Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 37
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)
- Lot Number: RA-27
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corp
See all →- ModerateTerumo Cardiovascular Procedure Kit Recall for Shipping Damage
FDA (Devices) · 2022-04-27
- ModerateTerumo Tubing Pack Convenience Kit Recalled for Incorrect Expiration Date
FDA (Devices) · 2018-08-01
- SevereTerumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks
FDA (Devices) · 2018-04-18
- ModerateTerumo Cardiovascular Procedure Kits Recalled for Incorrect Tubing Coating Labeling
FDA (Devices) · 2016-09-07
- HighTerumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators
FDA (Devices) · 2015-09-30
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateTerumo Cardiovascular Procedure Kit Recalled for Undeclared Natural Rubber Latex
FDA (Devices) · 2019-03-06
- ModerateTerumo Cardiovascular Procedure Kits Recalled for Incorrect Tubing Coating Labeling
FDA (Devices) · 2016-09-07
- ModerateTerumo Cardiovascular Procedure Kit Recall for Shipping Damage
FDA (Devices) · 2022-04-27
- ModerateTerumo Tubing Pack Convenience Kit Recalled for Incorrect Expiration Date
FDA (Devices) · 2018-08-01
- HighTerumo Cardiovascular Procedure Kit Recall for Pumphead Leaks
FDA (Devices) · 2014-07-23
- SevereTerumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
FDA (Devices) · 2015-09-30