Anspach Custom Circular ePLUS-FP Medical Device Recall for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Circular ePLUS-FP devices 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, but the source text does not report any illnesses, injuries, or specific safety hazards, only a failure to meet Quality System requirements. This aligns with a moderate severity rating for a voluntary precautionary recall without reported harm.
Plain-English summary
The Anspach Effort, Inc. is recalling Anspach Custom Circular ePLUS-FP devices. The recall is identified by FDA recall number Z-1901-2014.
The reason for the recall is that the units were not manufactured consistently with Quality System requirements. The source text does not specify the exact nature of the manufacturing inconsistencies or any specific safety hazards associated with the defect.
The affected devices are identified by Part Number 98-0048 and Serial Number 200073101. The devices were 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. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- 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 (2)
- Part Number: 98-0048
- Serial Number: 200073101.
Distribution
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 →Related recalls
Same manufacturer · The Anspach Effort, Inc.
See all →- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Separate During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighAnspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Detach During Surgery
FDA (Devices) · 2023-01-18
Same hazard · quality system non compliance
See all →- HighDiagnostic test products recalled by Universal Meditech for missing FDA clearance
FDA (Devices) · 2023-11-01
- HighUnauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech
FDA (Devices) · 2023-11-01
- ModeratePregnancy test strips recalled for lack of FDA authorization and quality documentation
FDA (Devices) · 2023-11-01
- ModerateValorem Surgical Recalls Pallas M Tapper Spinal Fixation Devices
FDA (Devices) · 2017-08-16
- ModerateValorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues
FDA (Devices) · 2017-08-16