Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions for use were unclear.
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 and involves labeling errors where indications for use were broader than validated. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving labeling issues.
Plain-English summary
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The specific product identified is the MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. A total of 6,439 units are included in this recall.
The recall was initiated after the company determined that the indications for use were broader than the validation of the MCA Cutting Burrs. Additionally, the directions for use did not clearly state the correct intended use of the device. The device is intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Belgium, Canada, Switzerland, Spain, France, the United Kingdom, Italy, Japan, the Netherlands, Sweden, and South Africa. The source text does not specify further instructions for consumers or healthcare providers beyond the initiation of the recall.
The recalled product
- Product
- MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 6,439
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 (1)
- All lots are included in recall
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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 21 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
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateAnspach Recalls Micro Curved Attachments Due to Unclear Directions for Use
FDA (Devices) · 2014-01-15
- ModerateAnspach MCA Cutting Burr Recalled for Inadequate Labeling Instructions
FDA (Devices) · 2014-01-22
- ModerateAnspach Otologic Diamond Ball Burrs Recalled for Missing Coating
FDA (Devices) · 2016-05-25
- ModerateAnspach 7mm Diamond Ball Dissection Tools Recalled for Labeling Inconsistency
FDA (Devices) · 2015-08-05
- HighAnspach Carbide Cutting Burrs Recalled Due to Fracture During Use
FDA (Devices) · 2014-01-22
- ModerateAnspach Cutting Bur Recall Due to Incorrect Product Code Labeling
FDA (Devices) · 2014-05-21