Medline Convenience Kits Recalled for Sterilization Equipment Calibration
Medline is recalling certain Dental Pack and Surgical Pack convenience kits due to calibration issues with sterilization equipment that may affect sterility assurance. Approximately 3,508 units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical devices where sterility assurance may be compromised. Although no illnesses or injuries have been reported, compromised sterility of surgical and dental devices presents a direct risk of harm to patients who may use them. The hazard is not merely theoretical but is based on an identified manufacturing defect.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, including Model DYNDA3003 (Dental Pack) and Model DYNJ87157 (Gullo Surgical Pack). The recall affects approximately 3,508 units distributed nationwide.
The recall was initiated after Medline identified calibration issues with the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level of the recalled products.
Healthcare facilities and providers who have received these kits should contact Medline Industries, LP for instructions on return or replacement. Affected lot numbers include multiple batches of the Dental Pack (DYNDA3003) and one lot of the Surgical Pack (DYNJ87157), identified by their respective UDI codes and lot numbers as detailed in FDA recall notice Z-2096-2026.
The recalled product
- Product
- Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
- Manufacturer
- Medline Industries, LP
- Hazard
- sterilization-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYNDA3003
- UDI-DI: 10195327257484(each)
- 40195327257485(case)
- Lot Number: 22JBH446
- 2) DYNDA3003
- Lot Number: 23ABA768
- 3) DYNDA3003
- Lot Number: 23BBS986
- 4) DYNDA3003
- Lot Number: 23CBN951
- 5) DYNDA3003
- Lot Number: 23CBT510
- 6) DYNDA3003
- Lot Number: 23CBV199
- 7) DYNDA3003
- Lot Number: 23GBA134
- 8) DYNDA3003
- Lot Number: 23JBH393
- 9) DYNDA3003
- Lot Number: 24BBH600
Distribution
Distributed nationwide across the United States.