Medline Convenience Kits for C-Section and Obstetric Procedures
Medline Industries is recalling 12,529 units of sterile surgical convenience kits used in cesarean section and obstetric procedures worldwide due to equipment calibration issues that may compromise sterilization assurance.
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: This is an FDA Class II recall involving sterile medical devices used in surgical procedures. The calibration issues create a potential risk to sterility assurance without any reported illness or injury, meeting the High threshold for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple models of C-Section and obstetric delivery convenience kits distributed nationwide and worldwide. The recall affects 12,529 units across 55 different product models with various lot numbers.
The recall was initiated due to identified calibration issues with equipment used to sterilize and package these medical devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
These kits are used in cesarean section and obstetric delivery procedures. Healthcare facilities that have received affected products should contact Medline for information regarding the specific lot numbers and model numbers involved in this recall. Consult the FDA recall notice Z-2110-2026 for the complete list of affected model numbers and lot numbers.
The recalled product
- Product
- Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model…
- Manufacturer
- Medline Industries, LP
- Affected units
- 12,529
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) CDS820080N
- UDI-DI: 10195327278014(each)
- 40195327278015(case)
- Lot Number: 23IMB818
- 2) CDS983523G
- UDI-DI: 10195327283681(each)
- 40195327283682(case)
- Lot Number: 23IBS984
- 3) CDSCCR611O
- UDI-DI: 10193489367904(each)
- 40193489367905(case)
- Lot Number: 21CBN328
- 4) CDSCCR611O
- Lot Number: 21LBC555
- 5) CDSCCR611O
- Lot Number: 21WBA953
- 6) CDSCCR611P
- UDI-DI: 10195327065850(each)
- 40195327065851(case)
- Lot Number: 22BBH774
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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