The Recall Desk
ModerateFDA (Devices)·Z-1999-2017·Announced 2017-05-10

Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval

The Anspach Effort, Inc. is recalling 11.0cm Long Attachments for pneumatic systems because the supplied directions for use did not contain 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 specific defect is 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 3,504 units of the 11.0cm Long Attachment used in pneumatic systems. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.

The affected products were distributed worldwide, including US Nationwide in the states of HI, DC, Puerto Rico, Guam, and Japan. The recall includes all serial numbers shipped to customers prior to September 27, 2016, identified by DFU 18-0048 and Part No. LONG.

Consumers should stop using the affected attachments and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.

The recalled product

Product
11.0cm Long Attachment Product Usage: Pneumatic system
Affected units
3,504

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 18-0048
  • Part No. LONG.

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 →