Medline Industries Recalls 4,853 Convenience Kits Over Sterilization Calibration Issues

What Happened

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

Which Products Are Affected

The recall affects 4,853 units distributed nationwide in the United States and worldwide. Affected products include 35 different kit configurations with various model numbers and lot numbers. Key models include:

• Ophthalmic Kits: Models DYKMBNDL104, DYKMBNDL104A, DYKMBNDL159, DYKMBNDL180, DYKMBNDL42, DYKMBNDL98, DYKMBNDL98A, DYKMBNDL98B.
• Surgical Packs: Models DYNJ17219C (Minor Eye), DYNJ38791M (Peds Eye/Muscle), DYNJ41207C (Eye Pack), DYNJ42043I (Ophthalmic), DYNJ44852J (Breast Reconstruction), DYNJ45585C (Custom Eye), DYNJ47859B/C (Eye Plastic), DYNJ53019A (Cataract), DYNJ54869A (Cataract), DYNJ55280B (Vitrectomy), DYNJ61779C (NDNW-Eye), DYNJ62306 (Eye PK), DYNJ64220 (Vitrectomy), DYNJ65808C (OSC Breast), DYNJ67973A (Mills Cataract), DYNJ68367B (Eye Pack), DYNJ68875D/F/G (Cataract), DYNJ902256C (Ophtho Plastic), DYNJ907495 (Retinal), DYNJ909924 (Cataract), DYNJ909925 (Combo Eye), and DYNJ909929 (Vitrectomy).
• Oncology Kits: Models DYKMBNDL43B (Surg Onc Port Insertion) and DYKMBNDL84B (Surg Onc Excision Breast).

Specific lot numbers range from 20XBF509 to 25EBG033. The recall number is Z-1420-2026.

What You Should Do

Medline Industries, LP notified affected customers via letter starting on January 7, 2026. Healthcare providers and facilities should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and not used in clinical settings. For information regarding returns or replacements, contact Medline Industries, LP at their headquarters at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

This recall is classified as Class II, indicating that the use of these potentially non-sterile medical kits could cause temporary or medically reversible adverse health consequences, such as post-surgical infections. Maintaining a high Sterility Assurance Level is critical for patient safety during ophthalmic and surgical procedures.

Source

Recall information provided by the FDA. Event ID: 98329.