Anspach Effort Recalls Bearing Sleeves Due to Missing Service Interval Instructions
The Anspach Effort, Inc. is recalling 224 Bearing Sleeves 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, but the specific defect is a missing service interval in the documentation, which is a minor labeling/documentation error without reported injuries or illnesses.
Plain-English summary
The Anspach Effort, Inc. is recalling 224 units of the Bearing Sleeve, 15CM Curved, which is used in pneumatic systems. The recall is being conducted because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected products are identified by Part No. MA-15C and DFU 18-0099. The recall includes all serial numbers shipped to customers prior to 09/27/2016. These products were distributed worldwide, including in the United States (specifically HI and DC), Puerto Rico, Guam, and Japan.
Consumers should contact The Anspach Effort, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 224
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 18-0099
- Part No. MA-15C.
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 →- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
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 5 cm Extension Bearing Sleeve Recalled for Quality Issues
FDA (Devices) · 2014-07-02
- ModerateAnspach 8 mm Coarse Headless Screw Recall for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- HighAnspach Effort Recalls Bearing Sleeve Devices Due to Metal Fragment Risk
FDA (Devices) · 2013-02-13
- ModerateAnspach 8 mm Coarse Threaded Headless Bone Screw Recalled for Quality Issues
FDA (Devices) · 2014-07-02
- ModerateAnspach Custom Device Autolube III Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach Recalls Arthroscopic Suture Anchor Assemblies for Quality System Non-Compliance
FDA (Devices) · 2014-07-02