Anspach Effort Recalls 11.25cm Black Max Attachments for Missing Service Interval
The Anspach Effort, Inc. is recalling 216 units of the 11.25cm Black Max attachment because the supplied directions for use did not include a recommended service interval.
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 indicates a documentation issue (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 216 units of the 11.25cm Attachment, Black Max. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval. The product is identified by Part No. B-BLUE-S and DFU 18-0062.
The recalled units were distributed worldwide, including nationwide in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. All serial numbers were shipped to customers.
Consumers who have this product should stop using it and contact The Anspach Effort, Inc. for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 11.25CM ATTACHMENT, BLACK MAX
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 216
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 (3)
- All serial numbers shipped to customers
- DFU 18-0062
- Part No. B-BLUE-S.
Distribution
Part of a larger recall action
This product is one of 103 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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