Medline Industries Recalls Dental Packs Due to Potential Sterility Issues
Medline Industries, LP has voluntarily recalled 2,236 units of its Dental Pack convenience kits because of equipment calibration issues that may affect product sterility.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific dental packs after identifying calibration issues with equipment used in the sterilization and packaging process. While the products underwent sterilization cycles, the calibration errors may have compromised the sterility assurance level (SAL) of the devices, potentially leaving the products non-sterile.
Which Products Are Affected
The recall involves Medline Convenience Kits: DENTAL PACK, Model Number DYNDA3003. A total of 2,236 units are affected. The products were distributed worldwide and nationwide across the United States.
Product Details:
- Model Number: DYNDA3003
- UDI-DI: 10195327257484 (each), 40195327257485 (case)
- Lot Numbers: 24EMC989, 24CMF059A, 24CMF059, 24BBH600, 23JBH393, 23GBA134, 23CBV199, 23CBT510, 23CBN951, 23BBS986, 23ABA768, and 22JBH446.
What You Should Do
Medline began notifying affected customers via letter 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. For instructions on returns or further information, contact Medline Industries, LP at their Northfield, IL headquarters.
Why This Matters
Compromised sterility in medical or dental equipment can lead to an increased risk of infection for patients during clinical procedures. Ensuring the sterility assurance level is critical for patient safety and preventing healthcare-associated infections.
Source
Information provided by the FDA. Recall Number: Z-1393-2026.
Source: FDA Official Notice