The Recall Desk
ModerateFDA (Devices)·Z-1960-2017·Announced 2017-05-10

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.

What this means for you

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
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

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 103 products in this recall →