Medline Industries Recalls 3,561 Medical Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of various medical convenience kits after identifying calibration issues with equipment used during the sterilization and packaging process. While the affected products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the devices. This recall has been classified as a Class II recall by the FDA.

Which Products Are Affected

A total of 3,561 units are included in this recall. The affected products were distributed worldwide and nationwide across the United States. The recall involves the following 10 kit types and specific model numbers:

1. ENDO KIT W/SYRINGE: Model DYKE1743 (Lots: 23KBQ544, 23JBO193)
2. BGMC ANGIOGRAPHY PACK-LF: Model DYNJ0800934D (Lots: 21EBQ851, 21DBA951, 21BKA527, 21AKB217)
3. GENERAL ENDO PACK-LF: Model DYNJ0842873J (Lot: 21ADA204)
4. OR ANGIO PACK-LF: Model DYNJ43415C (Lots: 22EBI127, 22EBF322, 22CBF108)
5. ANGIO PACK II: Model DYNJ44066A (Lots: 22CLA012, 22BLA508, 21KLA332, 21HLA812, 21CLA325)
6. SOUTH CATH LAB PACK: Model DYNJ61978A (Lot: 20LDB953)
7. BIOPSY ANGIO TRAY ALEX: Model DYNJ63542B (Lot: 23DBP359)
8. SURGICAL TECH KIT: Model DYNJ907452 (Lot: 20LBW791)
9. ANGIOGRAPHY PACK: Model DYNJC2371G (Lot: 23BBT999)
10. SPECTRUM HEALTH CATH PACK-LF: Model PHS853965G (Lot: 21ADA067)

What You Should Do

Medline Industries notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information, consumers may contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

Sterility is critical for medical devices used in surgical and clinical settings. If the sterility assurance level is compromised, there is an increased risk of patient infection or other serious health complications during medical procedures.

Source

FDA Recall Notice Z-1388-2026 - Medline Industries, LP