Anspach Effort Pneumatic Attachment Recalled for Missing Service Interval Instructions
The Anspach Effort, Inc. is recalling 8.0CM Heavy Duty Medium Pneumatic Attachments because the supplied directions for use did not contain a recommended service interval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard is a documentation issue (missing service interval) rather than a direct physical defect, fitting the 'Moderate' criteria for minor labeling/documentation errors without reported injuries.
Plain-English summary
The Anspach Effort, Inc. is recalling 1,202 units of the 8.0CM Heavy Duty Medium Attachment, Part No. MEDIUM-HD, 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 and DC, Puerto Rico, Guam, and Japan. The recall includes all serial numbers shipped to customers prior to 09/27/2016, associated with DFU 18-0048.
Consumers who have this product should stop using it and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- 8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 1,202
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-HD.
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 →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateAnspach Custom Medium Attachment Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach Custom 5 cm Extension Bearing Sleeve Recalled for Quality Issues
FDA (Devices) · 2014-07-02
- ModerateAnspach 13 mm Drill with Depth Stop Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach 8 mm Coarse Headless Screw Recall for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach Custom MDA Tube Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach Modified QD11 Attachment Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02