# Class II recall Z-0181-2027: Medline Industries, LP

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0181-2027 |
| Recalling firm | Medline Industries, LP |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Convenience Kits containing CONMED AirSeal Access Ports    HERNANDEZ DAVINCI ACC BUNDLE M	  	DYNJ911258    KIT ROBOTICS UROLOGY PROSTATE	  	DYKMBNDL116I    ROBOTIC CHEST	  	DYNJ910997  	DYNJ910997A  	  RR-DAVINCI PROSTATE ACCESSORY	  	DYNJ63392D    UROLOGY LAPAROSCOPIC - 51638	  	DYNJ908720B  	  UROLOGY ROBOT ADD ON PACK	  	DYNJ85189 |
| Reason | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. |
| Quantity | 3,551 kits |
| Distribution | US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. |
| Recall initiated | 2026-08-31 |
| Reported | 2026-10-21 |
| Firm location | Northfield, IL, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0181-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.