Medline medical convenience kits packaged as: ADULT CATH… recallZ-1327-2026 · Medline Industries, LP · initiated Dec 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging change control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1327-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 24, 2025
- Posted by the FDA
- Feb 9, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 1350 kits
- Product code
- OES
- Distribution
- US Nationwide distribution.
Product description
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Code information (models, lots, serial numbers)
UDI/DI 10193489918113, Lot Number 25EBD613
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNDC3109Medline Industries, Inc. · Cardiac catheterization kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98284).
- Z-1326-2026 · Open, ClassifiedMedline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
- Z-1328-2026 · Open, ClassifiedMedline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
- Z-1330-2026 · Open, Classified1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU …
- Z-1331-2026 · Open, ClassifiedMedline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
- Z-1332-2026 · Open, ClassifiedMedline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
- Z-1333-2026 · Open, ClassifiedMedline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
- Z-1334-2026 · Open, ClassifiedMedline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE T…
- Z-1335-2026 · Open, ClassifiedMedline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page