Anspach Effort Recalls XMAX Pneumatic Drill System for Missing Service Interval
The Anspach Effort, Inc. is recalling 554 XMAX Pneumatic Drill Systems because the supplied directions for use did not include 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, but the specific defect is a documentation issue (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 554 units of the XMAX Motor (Pneumatic Drill System). 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, Puerto Rico, Guam, and Japan. The recall covers all product shipped prior to 09/27/2016, identified by DFU 18-0040 and Part No. xMAX.
Consumers with this product should stop using it and contact The Anspach Effort, Inc. for further instructions on how to obtain the correct service interval information.
The recalled product
- Product
- XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 554
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 product shipped prior to 09/27/2016
- DFU 18-0040
- Part No. xMAX.
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
Similar recalls
- ModerateAnspach Custom Pneumatic Motor Recall for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- HighAnspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk
FDA (Devices) · 2014-01-15
- SevereAnspach Pneumatic Drill System Recalled Due to Hose Rupture Risk
FDA (Devices) · 2014-01-15
- ModerateAnspach Custom Pneumatic Motor Devices Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach XMax Motor Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach Effort Recalls Pneumatic Systems Operating Manual and Product Catalog
FDA (Devices) · 2013-11-20