Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices 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, and the source text cites a manufacturing quality issue without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling Anspach Custom Devices. The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The recalled products include the 3mm Fluted Ball for Adjustable 25cm Mia Attachment (Part Number SP-4604-00). The distribution pattern indicates worldwide distribution, including specific US states and international locations such as Canada, Japan, Hungary, Korea, and Sweden.
Consumers should contact The Anspach Effort, Inc. for further instructions regarding the recall.
The recalled product
- Product
- ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 19
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 (4)
- Part Number: SP-4604-00
- Serial Numbers: 200282
- 200299
- 200096.
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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