FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
- Recall number
- Z-2024-2014
- Recalling firm
- Aesculap, Inc.
- Product
- Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
- Status
- Terminated
- Initiated
- 2014-06-13
- Posted
- 2014-07-09
- Terminated
- 2014-10-07
- Reason
- Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.
- Root cause
- Labeling design
- Action
- A correction and removal notification, dated June 13, 2014, was sent to end users, sales reps, and distributors which described the product, problem, and actions to be taken.
- Quantity
- 11
- Distribution
- Distributed in the states of IL, NY, GA, and RI.
- Lot, serial or model codes
- Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055
- 510(k) numbers
- ["K990090"]
- PMA numbers
- not on file
- Product code
- GAR
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- 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