Medline Convenience Kit Drape Packs Recalled for Weak Seal Risk
Medline Industries is recalling UNIVERSAL DRAPE PACK convenience kits because their breather pouches may have open or weak seals, potentially compromising sterility of the packaged kits.
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 of sterile medical kits where a packaging defect (weak or open seals) creates a risk of loss of sterility, a serious risk of harm to patients. No illnesses or injuries are reported, but the hazard is not merely theoretical—compromised sterility of surgical kits poses direct patient risk.
Plain-English summary
Medline Industries, LP is recalling UNIVERSAL DRAPE PACK convenience kits (Model Number DYNJCD0239) due to a potential for open or weak seals on the breather pouches used to package these sterile kits. The affected lot is 24IBR482, consisting of 90 units distributed worldwide including the US, Canada, Mexico, Panama, and the US Virgin Islands.
Breather pouches with compromised seals may allow the packaged sterile kits to lose their sterile condition, which could affect their safety and effectiveness for use in various medical procedures.
Consumers and healthcare facilities that have received these kits should stop using them and contact Medline Industries for further instructions regarding return or replacement of the affected products.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 90
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) DYNJCD0239
- UDI-DI: 10889942245901(each)
- 40889942245902(case)
- Lot Number: 24IBR482
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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighMedline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk
FDA (Devices) · 2024-10-30
- HighMedline Medical Procedure Convenience Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk
FDA (Devices) · 2024-10-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue
FDA (Devices) · 2024-10-30
- HighMedline Radiology Procedure Pack Breather Pouches Recalled for Seal Defects
FDA (Devices) · 2022-11-09