Medline Industries Recalls C-Section Convenience Kits Due to Sterility Assurance Concerns
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Medline Industries, LP has voluntarily recalled over 4,500 C-Section convenience kits and trays because equipment calibration issues may have compromised product sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on March 4, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Medline Industries, LP has initiated a voluntary recall of various C-Section convenience kits and trays. The company identified calibration issues with the equipment used to sterilize and package these medical devices. While the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the affected units.
Which Products Are Affected
The recall involves 4,525 units distributed nationwide in the U.S. and worldwide. Affected products include 36 different model configurations, including but not limited to:
- C-SECTION PACK: Models CDS820080N, DYNJ23544F, DYNJ32632F, DYNJ38801F, DYNJ49224I, DYNJ56523C, DYNJ59387L, DYNJ64549B, DYNJ904329D, DYNJ909507
- C-SECTION TRAY: Models DYNJ15494G, DYNJ19529P, DYNJ19529Q, DYNJ19529R, DYNJ19529S, DYNJT3407
- C-SECTION CDS: Model CDS983523G
- C-SECTION: Models CDSCCR611O, CDSCCR611P, DYNJ41444F, DYNJ904697F, DYNJ907999A, DYNJ909058
- LUD C-SECTION-LF: Model DYNJ0101616I
- C-SECTION PACK-LF: Models DYNJ21550Q, DYNJ35100I
- SCRIPPS SW C-SECTION PACK-LF: Model DYNJ40129C
- C SECTION PACK-LF: Model DYNJ52387I
- C SECTION PACK: Models DYNJ67347A, DYNJ69778A
- B-C SECTION BAYSTATE: Models DYNJ900602I, DYNJ900602K
- PAD C-SECTION: Model DYNJ902134C
- RICH C-SECTION: Model DYNJ902182J
- KIT C SECTION: Model DYNJ906966G
- TR-C SECTION PACK-LF: Model PHS583549002B
Specific lot numbers and UDI-DI codes are associated with this recall. Notable lot numbers include 23IMB818, 23IBS984, 21WBA953, and 22IBG757, among others.
What You Should Do
Medline began notifying customers of the recall via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model and lot numbers. Affected products should be quarantined and handled according to the instructions provided in the firm's notification letter. For more information, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
Sterility is essential for surgical kits used in C-section procedures. If the sterility assurance level is compromised, there is an increased risk of infection for patients undergoing surgery.
Source
This information is based on an official recall notice from the FDA under recall number Z-1417-2026.
Original source: FDA Official Notice ↗
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