The Recall Desk
ModerateFDA (Devices)·Z-1933-2017·Announced 2017-05-10

Anspach Effort Foot Control Irrigation System Recalled for Missing Service Interval

The Anspach Effort, Inc. is recalling foot control irrigation 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 source text identifies the issue as a missing service interval in the documentation without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity documentation issue.

Plain-English summary

The Anspach Effort, Inc. is recalling one foot control irrigation system, a pneumatic system, because the supplied Directions for Use (DFU) did not contain a recommended service interval.

The recalled product is identified by Part No. AL-III-IRR and DFU 18-0040. The recall includes all product shipped prior to 09/27/2016. Distribution was worldwide, including US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan.

Consumers should stop using the product and contact The Anspach Effort, Inc. for further instructions.

The recalled product

Product
Foot control irrigation system Product Usage: Pneumatic system
Affected units
1

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 product shipped prior to 09/27/2016
  • DFU 18-0040
  • Part No. AL-III-IRR

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 →