Anspach Effort Recalls IMRI Short Attachment Pneumatic System Components
The Anspach Effort, Inc. is recalling 14 IMRI Short Attachment units 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 source text identifies the issue as a missing service interval in the documentation rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity documentation issue.
Plain-English summary
The Anspach Effort, Inc. is recalling 14 units of the IMRI Short Attachment, a component used in pneumatic systems. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.
The affected units were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall covers all serial numbers shipped to customers prior to September 27, 2016, associated with DFU 18-0093 and Part No. IMRI-SHORT.
Consumers who possess these units should stop using them and contact The Anspach Effort, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 14
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 18-0093
- Part No. IMRI-SHORT.
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 Medium Attachment Recalled for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- ModerateAnspach Custom QD11 Attachment Recalled 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
- ModerateAnspach 13 mm Drill with Depth Stop 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
- HighAnspach MIA 16 Minimally Invasive Attachment Recalled for Sterility Failure
FDA (Devices) · 2014-01-22