ANSPACH***Custom XMax Motor — Class II medical device recall Z-1897-2014
Terminated recall by The Anspach Effort, Inc., reported 2014-07-02, distributed in AL, CA, FL, IA, IL, KY, MN, MS…. The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were n
| Recall number | Z-1897-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2012-11-28 |
| Classified | 2014-06-25 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2014-08-07 |
| Distributed | AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX |
| Countries outside the US | CA, HU, JP, KR, SE |
| Quantity | 45 |
| Serial numbers | 200057701, 200057702, 200057801, 200057802, 200058301, 200058302, 200058401, 200058402, 200069301, 200069302, C05301514406, C06301529102, C06301529106, C08301529002, C08301529006, C08301529007, C8301529004, D31200076201, D31200076202, D31200076203, D31200076204, D31200079001, D31200079002, D31200079003, D31200079004 and 12 more |
| Model numbers | 98-0039, 98-0040, 98-0050, 98-0057 |
Product
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
Reason for recall
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.