The Recall Desk
ModerateFDA (Devices)·Z-1900-2014·Announced 2014-07-02

Anspach Custom Device Speed Reducer Recalled for Quality System Defects

The Anspach Effort, Inc. is recalling two Custom Device Speed Reducer units because they were not manufactured consistently with Quality System requirements.

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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

The Anspach Effort, Inc. is recalling two units of the Anspach Custom Device Speed Reducer with Bumper (Part Number: 98-0044; Serial Number: E16200088601). The recall was initiated because the units were not manufactured consistently with Quality System requirements.

The affected devices are prescription-only and intended to be used with Anspach Systems. The recall covers two units distributed worldwide, including in the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden.

Consumers and healthcare providers should contact The Anspach Effort, Inc. for further instructions regarding the recall and potential replacement or repair of the affected units.

The recalled product

Product
ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Custom Device
Hazard
Affected units
2

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 (2)

  • Part Number: 98-0044
  • Serial Number: E16200088601.

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 45 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 45 products in this recall →

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Same manufacturer · The Anspach Effort, Inc.

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