FDA Medical Device Recalls (openFDA)
Madison Polymeric Engineering: First Step Draco Pad, Product Number EP-4D
- Recall number
- Z-1925-2019
- Recalling firm
- Madison Polymeric Engineering
- Product
- First Step Draco Pad, Product Number EP-4D
- Status
- Terminated
- Initiated
- 2019-05-08
- Posted
- not on file
- Terminated
- 2020-07-06
- Reason
- This product has been contaminated with Stenotrophomonas lactiubi.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers.
- Quantity
- 10570
- Distribution
- The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.
- Lot, serial or model codes
- Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNL
- Firm FEI
- 3001451466
- Firm city
- Branford
- Firm state
- CT
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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