Agency classClass IIOur severity:High FDA (Devices)·Z-1161-2023·Announced 2023-03-01

Sterile Oncology Port Access Tray Recalled for Sterilization Failure

Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.

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 medical device recall with no reported illnesses or injuries. The hazard is a manufacturing defect resulting in nonsterile components. Per the severity rubric, this is a risk-of-harm product where injury has not been reported, scoring as High (3).

Plain-English summary

Medline Industries, LP is recalling Sterile Oncology Port Access Tray, Item #DYNDC2239. The product is supplied in cases containing 20 sterile kits, each with an Ethicon Biopatch Protective Disk containing chlorhexidine gluconate. Approximately 4,360 trays are affected.

During manufacturing, some components were placed in the nonsterile portion of the tray and did not receive proper sterilization. This could result in components being nonsterile when used.

The affected trays were distributed nationwide to healthcare facilities in Arkansas, Colorado, and Georgia. Multiple lot numbers are involved with expiration dates between 2022 and 2024.

Healthcare providers should immediately stop using affected trays and contact Medline Industries for replacement units. Users can verify lot numbers and expiration dates from their packaging and the official FDA recall notice Z-1161-2023.

The recalled product

Product: Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Oncology / Sterile Tray
Hazard: sterilization-failure
Affected units: 4,360

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 (17)

UDI/DI (01) 40888277986412
Lot numbers 22OBD978
exp. 1/31/2023
22HBR887
exp. 12/31/2023
22GBD420
22EBK277
22EBK012
exp. 9/30/2023
22EBA934
exp. 1/31/2024
22ABK594
exp. 4/30/2023
21KBS545
exp. 6/30/2022
and 21JBL152
exp. 2/28/2023.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Critical
Intubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
Severe
Medline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
High
Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
High
Surgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
High
Surgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03

Same hazard · sterilization failure