Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval
The Anspach Effort, Inc. is recalling 8.0cm Medium Pneumatic System Attachments 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: This is an FDA Class II recall involving a documentation issue (missing service interval) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 1,802 units of the 8.0cm Medium 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 including PR and the countries of Guam and Japan. The recall includes all serial numbers shipped to customers prior to 09/27/2016, identified by DFU 18-0048 and Part No. MEDIUM.
Consumers should stop using the product and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- 8.0cm Medium Attachment Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 1,802
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. MEDIUM.
Distribution
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 →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 · documentation error
See all →- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01