Anspach Recalls 130 MRI Fluted Balls Due to Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 130 units of 4mm Fluted Balls for MRI 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 cites only Quality System non-compliance without reporting specific injuries, illnesses, or significant hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 130 units of the Anspach 4mm Fluted Ball for MRI (Part Number SP-3014-00). The recall involves specific serial numbers: 200141, 200118, 200119, 200121, 200122, 200058, 200048, 200142, 200057, 200047, 200077, 200049, and 200120.
The reason for the recall is that the units were not manufactured consistently with Quality System requirements. The source text does not specify the exact nature of the manufacturing inconsistencies or any associated safety hazards.
The affected devices were distributed worldwide, including to the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- ANSPACH***REF SP-3014-00***4mm Fluted Ball 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
- 130
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 (14)
- Part Number: SP-3014-00
- Serial Numbers: 200141
- 200118
- 200119
- 200121
- 200122
- 200058
- 200048
- 200142
- 200057
- 200047
- 200077
- 200049
- 200120.
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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