The Recall Desk
HighFDA (Devices)·Z-1419-2026·Announced 2026-02-25

Robotic surgery kits recalled over sterilization equipment calibration issues

Medline is recalling 7,725 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

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: Scored 3 under the risk-of-harm criterion: the firm states the calibration issues have the potential to impact the sterility assurance level of products used in sterile procedures, and no injuries are reported.

Plain-English summary

Medline convenience kits are being recalled by Medline Industries, LP, covering the BAP North Robotic Surgery CDS under model number CDS982407N, Tot/GYN Lithotomy CDS kits under CDS985431K and CDS985431O and a Kit Robotics GYN, among the model numbers listed in the enforcement record.

The record states Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. It states all products were exposed to the validated sterilization and packaging cycles, however the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.

The record lists 7,725 units, with model numbers, UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.

A sterility assurance level that cannot be relied on carries an infection risk for products used in sterile procedures. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Medline's instructions.

The recalled product

Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
Manufacturer
Medline Industries, LP
Category
Medical Device — Procedure kit
Hazard
Affected units
7,725

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) CDS982407N
  • UDI-DI: 10193489683004(each)
  • 40193489683005(case)
  • Lot Number: 21DBO201
  • 2) CDS982407N
  • Lot Number: 21CBD150
  • 3) CDS985431K
  • UDI-DI: 10195327451295(each)
  • 40195327451296(case)
  • Lot Number: 23GBM332
  • 4) CDS985431K
  • Lot Number: 23GBL932
  • 5) CDS985431O
  • UDI-DI: 10198459195006(each)
  • 40198459195007(case)
  • Lot Number: 25GBB847
  • 6) DYKMBNDL109A
  • UDI-DI: 10193489848779(each)
  • 40193489848770(case)
  • Lot Number: 21IBS290

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.

See all 42 products in this recall →

Related recalls

Same manufacturer · Medline Industries, LP

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Same hazard · sterility assurance

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