Medline Industries Recalls Surgical Procedure Kits
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Medline Industries, LP is recalling 15,806 units of various surgical kits due to potential sterility issues from equipment calibration problems.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. 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.
Which Products Are Affected
The recall covers 15,806 units of multiple devices distributed nationwide in the US and worldwide. Affected products include: 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 GYNE CDS, Model Number: CDS984243G; 6-9) ROBOTIC-LF, Model Numbers: CDS984543D, CDS984543F, CDS984543G, CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 15-16) KIT ROBOTICS UROLOGY PROSTATE, Model Numbers: DYKMBNDL116D, DYKMBNDL116F; 17-18) KIT GYN VAGINAL MAJOR, Model Numbers: DYKMBNDL119, DYKMBNDL119A; 19-20) KIT GYN ABDOMINAL MAJOR, Model Numbers: DYKMBNDL168, DYKMBNDL168A; 21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; plus numerous additional models and lot numbers (full list exceeds character limits in source). Recall number Z-2109-2026. Classification: Class II. Initiation date: January 7, 2026.
What You Should Do
No specific consumer action steps or contact information are provided in the source data.
Why This Matters
The potential impact on the sterility assurance level of these surgical devices distributed nationwide could affect product safety.
Source
FDA recall Z-2109-2026, ongoing Class II device recall by Medline Industries, LP.
Original source: FDA Official Notice ↗
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