The Recall Desk
ModerateFDA (Devices)·Z-1997-2017·Announced 2017-05-10

Anspach Effort Recalls IMRI Short Attachment Pneumatic System Components

The Anspach Effort, Inc. is recalling 14 IMRI Short Attachment units 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 identifies the issue as a missing service interval in the documentation rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity documentation issue.

Plain-English summary

The Anspach Effort, Inc. is recalling 14 units of the IMRI Short Attachment, a component used in pneumatic systems. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.

The affected units were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall covers all serial numbers shipped to customers prior to September 27, 2016, associated with DFU 18-0093 and Part No. IMRI-SHORT.

Consumers who possess these units should stop using them and contact The Anspach Effort, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
Affected units
14

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 prior to 09/27/2016
  • DFU 18-0093
  • Part No. IMRI-SHORT.

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 →