FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
- Recall number
- Z-2005-2017
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
- Status
- Terminated
- Initiated
- 2016-10-06
- Posted
- not on file
- Terminated
- 2019-07-26
- Reason
- Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Root cause
- Under Investigation by firm
- Action
- Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.
- Quantity
- 224
- Distribution
- Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
- Lot, serial or model codes
- All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15C.
- 510(k) numbers
- ["K042783"]
- PMA numbers
- not on file
- Product code
- BWN
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28