FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
- Recall number
- Z-1335-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
- Status
- Open, Classified
- Initiated
- 2025-12-24
- Posted
- 2026-02-09
- Terminated
- not on file
- Reason
- Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- Root cause
- Packaging change control
- Action
- Medline issued an URGENT MEDICAL DEVICE recall notice to its consignees on 12/24/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee locate and quarantine the affected units and respond to the notice using the website link: https://recalls.medline.com; Recall Reference #: R-25-257-FGX1, and the specific code listed in the notice. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors and those who further distributed the affected its were directed to notify those to whom the kits were distributed or transferred, and include those quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 216 kits
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 10195327379292, Lot Number 25EBJ785
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PKD
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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