Medline Industries Recalls Over 12,000 Surgical Convenience Kits Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of various surgical convenience kits due to concerns regarding their sterility. The company identified calibration issues with the equipment used to sterilize and package the devices. While all products were exposed to validated sterilization and packaging cycles, the identified calibration errors have the potential to impact the sterility assurance level (SAL) of the affected products.

Which Products Are Affected

The recall affects 12,418 units distributed nationwide in the United States and worldwide. The products are various Medline Convenience Kits used in robotic, gynecological, urological, and general surgical procedures. Affected model numbers include, but are not limited to:

• ROBOTIC GYN CDS-1: Model CDS982893I (Lot 24IBO240)
• GYN LAPAROSCOPY CDS: Model CDS983300J (Lot 21CDB781)
• KIT ROBOTICS UROLOGY PROSTATE: Models DYKMBNDL116D and DYKMBNDL116F
• OB PACK: Model DYNJ32706B (Lot 23EMB628)
• ROBOTIC-LF: Models CDS984543D, CDS984543F, CDS984543G, and CDS984543I
• KIT GYN ONCOLOGY LAP: Models DYKMBNDL100 and DYKMBNDL91
• D&C HYSTEROSCOPY: Model DYNJ901133A

Numerous other kits including GYN LAP LH, PROSTATE ROBOTIC PACK, and DAVINCI PACK are included in this recall. Specific UDI-DI codes and lot numbers are associated with each affected unit.

What You Should Do

Medline Industries notified affected customers via letter. Healthcare facilities and distributors should immediately check their inventory for the model numbers and lot numbers listed in the recall. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or replacement, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

Sterility is critical for medical devices used in surgical environments. If the sterility assurance level is compromised, there is an increased risk of patient infection or other adverse health consequences during or after surgical procedures. This Class II recall indicates that the use of these products may cause temporary or medically reversible adverse health consequences.

Source

Recall Number: Z-1415-2026; Attribution to the FDA.