Medline Surgical Device Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling approximately 15,806 surgical device kits used in gynecology, urology, and thoracic procedures. Calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves medical devices (surgical kits) with potential sterility compromise—a high-risk hazard affecting patient safety. Although no illnesses or injuries have been reported in the source text, the theoretical risk of infection from non-sterile surgical instruments used in invasive procedures constitutes a high-severity hazard.
Plain-English summary
Medline Industries, LP is recalling multiple surgical device kits distributed nationwide due to calibration issues with the equipment used to sterilize and package the devices. The recalled products include gynecology laparoscopy kits, robotic surgery kits, urology kits, and thoracic surgery kits manufactured under various model numbers.
The manufacturer identified that calibration problems with sterilization and packaging equipment may have affected the sterility assurance level (SAL) of the recalled devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration discrepancies have the potential to compromise the intended sterility of the devices.
Affected healthcare facilities and hospitals that received these devices should stop using the affected lot numbers immediately. Devices should be quarantined and returned to Medline Industries. Healthcare providers should review patient records for anyone who may have received surgery using recalled devices and consult with infection control and patient safety teams regarding next steps.
For a complete list of affected model numbers, lot numbers, and UDI codes, patients and healthcare providers should contact Medline Industries or visit the FDA's online recall database.
The recalled product
- Product
- See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC…
- Manufacturer
- Medline Industries, LP
- Affected units
- 15,806
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) CDS981504G
- UDI-DI: 10195327157968(each)
- 40195327157969(case)
- Lot Number: 25BDB744
- 2) CDS982407P
- UDI-DI: 10195327110116(each)
- 40195327110117(case)
- Lot Number: 23EBE997
- 3) CDS982407P
- Lot Number: 23GBL921
- 4) CDS982407P
- Lot Number: 23GBO574
- 5) CDS982407P
- Lot Number: 23IBC607
- 6) CDS982407P
- Lot Number: 23JBQ095
- 7) CDS982893I
- UDI-DI: 10889942208050(each)
- 40889942208051(case)
- Lot Number: 24IBO240
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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