FDA recall, , Moderate risk
Medline Medical Convenience Kits
Medline medical convenience kits may have an open seal on the packaging of the applicators.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP of Northfield, Illinois, is recalling 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. The recall was initiated on December 24, 2025, and was added to the FDA's Enforcement Report on February 9, 2026. Distribution was nationwide across the U.S.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline medical convenience kits packaged as: Adult Cath Securement DRSG, Kit SKU DYNDC3109
- UDI-DI
- 10193489918113
- Lot code
- 25EBD613
Medline medical convenience kits packaged as: Mercy Circumcision Tray, Kit SKU CIT6135B
- UDI-DI
- 10653160990666
- Lot code
- 25EBC648
Product details
Medline 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 TR, Kit SKU DT16615;
4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660;
5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665;
6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495;
7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A;
8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B;
9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.- UDI-DI
- 10653160997504
- 10653160323303
- 10653160259268
- 10653160283041
- 10653160283263
- 10653160320593
- 10193489499247
- 10198459078880
- 10195327475482
- Lot code
- 25EBQ881
- 25EBH827
- 25EBC730
- 25EBD629
- 25EBU086
- 25EMJ081
- 25EMJ351
- 25EBI085
- 25EBM451
Product details
1) 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 DYNDA2966A;
6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C;
7) PORT DRESSING KIT, Kit SKU DYNDC3107;
8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C;
9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250;
10) UMBILICAL VESSEL TRAY, Kit SKU UVT835;
11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.- UDI-DI
- 10653160351092
- 10653160996965
- 10198459005848
- 10889942815333
- 10193489917628
- 10889942816453
- 10653160995340
- 10653160289180
- 10193489388145
- Lot code
- 25EBC888
- 25EBO566
- 25EBD964
- 25EBN178
- 25EBL624
- 25EBC706
- 25EBN742
- 25EBC778
- 25EBO757
- 25FMI300
- 25EBE079
Medline medical convenience kits packaged as: Sterile Resuture Pack, Kit SKU DYNDL1980A
- UDI-DI
- 10195327379292
- Lot code
- 25EBJ785
Medline medical convenience kits packaged as: Anesthesia Artline Pack, Kit SKU DYNJ47387B
- UDI-DI
- 10193489217070
- Lot code
- 25EBJ414
Medline medical convenience kits packaged as
- Lot code
- 25EBC812
- 25FBH991
- 25EBC577
- 25EBS434
- 25FMG170
- 25EBK184
- 25EBM461
- 25EBD386
- 25FMD059
- UDI-DI
- 10193489437041
- 10889942582013
- Lot code
- 25EBP737
- 25EBE082
Some entries omit identifying details. Check the notice to confirm which units are affected.
Medline medical convenience kits packaged as: Pediatric Cath Securement DRSG, Kit SKU DYNDC3108
- UDI-DI
- 10193489918007
- Lot code
- 25EBD612
Medline medical convenience kits packaged as: Suture Removal Tray, Kit SKU DYNDR1277A
- UDI-DI
- 10195327379308
- Lot code
- 25EBO576
Medline medical convenience kits packaged as: Blood Culture Kit NS, Kit SKU DYNDH2088
- UDI-DI
- 10198459230363
- Lot code
- 25EBU508
- 25EBE330
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98284
- Recall numbers
- Z-1326-2026 to Z-1336-2026
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
