Medline Recalls Art-Line Surgery Packs Due to Non-Sterile Component
Medline is recalling 3,000 Art-Line Surgery Packs because a non-sterile CHG disk was attached to the outside of the sterile packaging, posing a potential infection risk.
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: The recall involves a risk-of-harm product (potential infection) where injury has not yet been reported, aligning with the High severity criteria.
Plain-English summary
Medline Industries, Inc. is recalling 3,000 units of Art-Line Surgery Pack-LF, STERILE. The recall involves specific lots of the product, which are distributed in California and New Mexico. The issue is that multiple surgical packs were assembled with a non-sterile CHG disk, labeled as "BIOPATCH" (kit component #52655), attached to the outside of the sterile pack.
This defect may pose a potential risk of infection. However, the kits have been in distribution since March 2016, and many have been used with no reported infections or adverse patient events. The BIOPATCH component is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.
Healthcare facilities and consumers should check their inventory for the affected item number DYNJ0165296D and the listed lot numbers. If found, these products should be removed from use and returned to Medline Industries, Inc. according to the recall instructions.
The recalled product
- Product
- Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
- Manufacturer
- Medline Industries, Inc.
- Category
- Medical Device — Surgical Packs
- Affected units
- 3,000
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 (8)
- Item number: DYNJ0165296D. Lots: 16CK2326
- 16DK0985
- 16DK2816
- 16GK2433
- 16IK0634
- 16KK0117
- 17AK1788
- 17BK2514
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medline Industries, Inc. 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 5 products in this recall →Related recalls
Same manufacturer · Medline Industries, Inc.
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighMedline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Arterial Line Insertion Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline medical procedure kits recalled due to potential non-sterile product risk
FDA (Devices) · 2024-10-30
- SevereMedline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions
FDA (Devices) · 2024-03-06
- HighMedline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk
FDA (Devices) · 2024-10-30
- SevereMedline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect
FDA (Devices) · 2014-03-05