Medline Convenience Kits Recalled for Potential Open or Weak Seals
Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile medical device with a defect that could compromise sterility and create risk of harm (potential contamination or use of non-sterile devices). No illnesses or injuries have been reported, but the potential for patient harm is present.
Plain-English summary
Medline Industries, LP is recalling select sterile convenience kits, including the CUSTOM BLOCK KEMP PACK-LF (Model Number DYNJ0371999G, Lot Number 24KBE129), due to a potential for open or weak seals on breather pouches used for packaging.
The defect may compromise the sterility of the kits. Open or weak seals could allow contamination or loss of sterile conditions during storage and transport.
The affected product was distributed worldwide, including the United States, Canada, Mexico, Panama, and the US Virgin Islands.
Customers who have purchased these kits should contact Medline Industries for further instructions regarding the affected units.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) DYNJ0371999G
- UDI-DI: 10889942061037(each)
- 40889942061038(case)
- Lot Number: 24KBE129
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 34 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · seal defect
See all →- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- HighMedical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
FDA (Devices) · 2026-08-12
- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
Similar recalls
- HighMedline Medical Procedure Convenience Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue
FDA (Devices) · 2024-10-30
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline medical procedure kits recalled for potential sterility breach
FDA (Devices) · 2024-10-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
FDA (Devices) · 2026-02-25