Asahi Kasei Recalls REXEED 15 LX Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling 24 units of REXEED 15 LX hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.
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 3/5 (High).
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 high-risk medical device (hemodialyzer) where adverse events have been observed, but the source explicitly states there is no sufficient information to conclusively link the events to the product, fitting the 'risk-of-harm products where injury has not yet been reported' or theoretical hazard criteria.
Plain-English summary
Asahi Kasei Medical Co., Ltd. is recalling 24 units of the REXEED 15 LX hemodialyzer, a dialysis filter. The recall involves lot number 296T78. The products were distributed worldwide, including in the United States (specifically Tennessee), Japan, and Germany.
The recall was initiated after the manufacturer became aware of a negative trend in the rate of adverse events that may be associated with a manufacturing change to certain lot numbers. The source text notes that there is currently no sufficient information to conclusively link these adverse events to the products.
Healthcare facilities and distributors should stop using the affected units and contact the recalling firm for instructions on return or disposal. Patients using these devices should consult their healthcare providers for guidance.
The recalled product
- Product
- Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
- Manufacturer
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Affected units
- 24
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: 296T78
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Asahi Kasei Medical Co., Ltd., Okatomi Plant 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 7 products in this recall →Related recalls
Same manufacturer · Asahi Kasei Medical Co., Ltd., Okatomi Plant
See all →- HighAsahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
FDA (Devices) · 2012-09-26
- HighAsahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
FDA (Devices) · 2012-09-26
- HighAsahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
FDA (Devices) · 2012-09-26
- HighAsahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
FDA (Devices) · 2012-09-26
- HighAsahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trends
FDA (Devices) · 2012-09-26
Same hazard · adverse event
See all →- SevereOlympus Thunderbeat Surgical Device Recall Over Adverse Events
FDA (Devices) · 2026-02-25
- SevereOlympus Thunderbeat Surgical Device Recall Due to Adverse Events
FDA (Devices) · 2026-02-25
- SevereCoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
FDA (Devices) · 2022-07-20
- SevereFDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events
FDA (Devices) · 2019-02-06
- SevereWest Pharma Services Recalls Vial2BAG DC 20mm Medical Devices
FDA (Devices) · 2019-02-06
Similar recalls
- SevereBaxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture
FDA (Devices) · 2019-07-10
- HighBaxter Recalls Revaclear 400 Dialyzers Due to Potential Fiber Rupture
FDA (Devices) · 2019-07-10
- HighRevaclear 400 Dialyzers Recalled for Potential Internal Blood Leaks
FDA (Devices) · 2022-12-28
- HighRevaclear 400 Dialyzer recall due to potential internal blood leaks
FDA (Devices) · 2022-12-28
- HighFresenius 2008T Hemodialysis Systems Recalled for Software Anomaly
FDA (Devices) · 2018-03-07
- HighArgon UltraStream Hemodialysis Catheter Recall Due to Luer Cracking
FDA (Devices) · 2014-10-01