Surgical angio port kits recalled for compromised sterile barrier
Medline is recalling 30 units of surgical angio port kits due to a perforated outer bag that prevents the external packaging from being sterile, creating a contamination risk during surgical use.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—compromised sterile barrier in surgical kits—represents a real risk of harm consistent with medical device contamination risks, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 30 units of MEDLINE ANGIO PORT KIT W/HIGH GRADE IN (Reorder Number DYNDC2691, Lot #22HMG394) distributed nationwide.
The recall was initiated due to perforations in the outer bag of the surgical convenience kit. These perforations prevent the external surface of the kit packaging from maintaining sterility. Only the contents inside the kit wrapping are guaranteed to be sterile, compromising the protective barrier essential for surgical use.
Healthcare facilities and healthcare providers who have received this kit should cease use immediately. The non-sterile external surface poses a contamination risk if the kit is used in surgical procedures.
If you have this product, contact Medline Industries for instructions on return or destruction of the affected units.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 30
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 (2)
- GTIN 40193489343800
- Lot # 22HMG394
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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 20 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
- SevereMedline Convenience Kits Recalled for Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- HighMedline Convenience Kits sterilization and packaging calibration issues recalled
FDA (Devices) · 2026-05-13
- HighMedline sterile convenience kits recalled for potentially weak packaging seals
FDA (Devices) · 2025-04-23
- HighMedline Convenience Kits Recalled Due to Defective Plastic Syringes
FDA (Devices) · 2024-09-18
- HighMedline Medical Procedure Convenience Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23