Anspach Recalls 113 MRI Fluted Routers for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 113 MRI fluted routers because they were not manufactured consistently with Quality System requirements.
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 does not report any injuries, illnesses, or specific safety hazards, only a failure to meet Quality System requirements. This aligns with the rubric for moderate severity involving voluntary or precautionary recalls without reported harm.
Plain-English summary
The Anspach Effort, Inc. is recalling 113 units of the Anspach 1.85mm x 16 mm Fluted Router for MRI. The recall is being conducted because the units were not manufactured consistently with Quality System requirements.
The affected devices are prescription-only and intended for use with Anspach Systems. The recall covers specific part numbers (SP-3013-00 through SP-3013-03) and serial numbers listed in the agency record.
Distribution was worldwide, including the United States and international locations such as Canada, Japan, Hungary, Korea, and Sweden. Users should contact the manufacturer for instructions on how to proceed with the recall.
The recalled product
- Product
- ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — MRI Accessories
- Affected units
- 113
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 (16)
- Part Number: SP-3013-00
- SP-3013-01
- SP-3013-02
- SP-3013-03. Serial Numbers: 200042
- 200044
- 200014
- 200056
- 200064
- 200055
- 200038
- 200013
- 310009
- 310007
- 20043
- 200145
- 200144.
Distribution
Part of a larger recall action
This product is one of 45 recalled by The Anspach Effort, Inc. 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.
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