Hemodialysis System Surdial DX (Nipro) – Screw Loosening Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Brand
Nipro Medical Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 00383790008815/Serial Numbers: 20EW0001 20EW0002 20EW0005 20EW0006 20EW0007 20EW0008 20EW0009 20EW0010 20EW0011 20EW0012 20EW0013 20EW0014 20EW0015 20EW0016 20EW0017 20EW0018 20EW0019 20EW0020 20EW0021 20EW0022 20EW0023 20EW0024 20EW0025 20EW0026 20EW0027 20EW0028 20EW0029 20EW0030 20EW0031 20EW0032 20EW0033 20EW0034 20EW0035 20EW0036 20EW0037 20EW0038 20EW0039 20EW0040 20EW0041 20EW0042 20EW0043 20EW0044 20EW0045 20EW0046 20EW0048 20EW0049 20EW0050 21EW0061 21EW0062 21EW0063 21EW0064 21EW0065 21EW0066 21EW0067 21EW0068 21EW0069 21EW0070 21EW0071 21EW0072 21EW0073 21EW0075 21EW0076 21EW0077 21EW0078 21EW0079 21EW0080 21EW0081 21EW0082 21EW0083 21EW0084 21EW0085 21EW0086 21EW0087 21EW0088 21EW0089 21EW0090 21EW0091 21EW0092 21EW0093 21EW0094 21EW0095 21EW0096 21EW0097 21EW0098 21EW0099 21EW0100 21EW0101 21EW0102 21EW0103 21EW0104 21EW0105 21EW0106 21EW0107 21EW0108 21EW0109 21EW0110 21EW0111 21EW0112 21EW0113 21EW0114 21EW0115 21EW0116 21EW0117 21EW0118 21EW0119 21EW0120 21EW0122 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Nipro Medical Corporation is recalling Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only due to Screw may loosen or fallout of Hemodialysis system. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Screw may loosen or fallout of Hemodialysis system
Recommended Action
Per FDA guidance
On October 27, 2025, Nipro issued a voluntary recall notification to affected consignees via E-Mail. In addition to provide information on the recall, Nipro asked consignees to take the following actions: 1. Please complete the enclosed SURDIAL DX Hemodialysis System Response Form to ensure the correct contact information for each machine to enable timely service appointments. 2. Pass this notice on to any facility that the Surdial DX Hemodialyis system has been transferred to. 3. Ensure all operators are aware of this recall notification. 4. Maintain a copy of the notification with affected machines. 5. Before each use, verify that the blood pump rotor assembly is securely fastened and operates smoothly without unusual vibration or looseness. 6. Monitor all impacted SURDIAL DX machines during operation for abnormal / unusual sounds, vibration or system error messages associated with the blood pump rotor assembly. 7. If any abnormality occurs, discontinue use immediately, safely remove the patient from the system following your facility protocols as appropriate.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026