Medline Industries Recalls Over 4,700 Convenience Kits Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of various Medline Convenience Kits due to potential compromises in sterility. The company identified calibration issues with the equipment used to sterilize and package the devices. While all products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the affected products.

Which Products Are Affected

A total of 4,757 units are affected by this recall. The products were distributed nationwide in the United States and worldwide. Affected items include 58 different kit configurations, such as:

• Plastic Bins with Misc Kits: Model ACC010499
• Urology Urethroplasty Kits: Model DYKMBNDL117C
• Plastic Surgery Kits (Abdominoplasty, Tissue Expansion, Rotational Flap): Models DYKMBNDL158, DYKMBNDL170 (A/B), DYKMBNDL182 (A/B), DYKMBNDL183 (A/B)
• Breast Procedure Packs (Reduction, Augmentation, Reconstruction): Models DYKMBNDL46, DYKMBNDL69 (A/B), DYKMBNDL78 (A/B), DYKMBNDL84 (C), DYNJ36469I, DYNJ44852K/M, DYNJ50957G, DYNJ55358G, DYNJ60210A, DYNJ69351, DYNJ83788, DYNJ83950A/B, DYNJ87444, DYNJT3283, DYNJT3417
• Facial and ENT Packs: Models DYKMBNDL34A, DYNJ0854650J, DYNJ38988J, DYNJ68844A, DYNJ907874A, DYNJ910462
• Major Surgery and Specialty Packs: Models DYNJ0785310G, DYNJ56737A, DYNJ64927F, DYNJ83884B, DYNJ86165, DYNJ86816, DYNJ902005I, DYNJ902558G, DYNJ903555D/F, DYNJ903849C, DYNJ907847A, PHS806973G

Specific lot numbers and UDI-DI codes for each model are listed in the official FDA enforcement report under recall number Z-1397-2026.

What You Should Do

Medline Industries, LP notified affected customers via letter starting January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model and lot numbers. Consumers or providers with questions regarding the return or replacement of these kits should contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

When the sterility assurance level of medical devices is compromised, there is an increased risk of patient infection or other serious health complications during surgical or clinical procedures.

Source

Recall initiated by Medline Industries, LP; documented by the FDA.