CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Convenience Kits containing Conmed AirSeal Access Ports recalled
Medline Industries is recalling Convenience Kits containing Conmed AirSeal Access Ports Hernandez Davinci Acc Bundle M, distributed nationwide in the US. The recall was initiated on 31 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0181-2027
- FDA event ID
- 99888
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2026
- FDA classified
- 15 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 31 Aug 2026 | Recall initiated by company | |
| 15 Oct 2026 | Classified by FDA | +45 days |
| 21 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
Nationwide ArizonaCaliforniaIndianaMarylandMissouriNew JerseyOhioWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
DYNJ911258 UDI-DI 10198459306723 Lots 25DMC798 25EMD961 25FMB704 25FMB704Z 25JMG936 25JMI469 DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710 26EBC888 26EBH673 DYNJ910997 UDI-DI 10198459241987 Lots 25DMB772 25GMA914 25GMB737 25GMC286 25GMJ509 25IMB332 25IME774 25KMB190 25KMF850 25LMB486 DYNJ910997A UDI-DI 10198459582103 Lots 25LLA437 26BLA786 26CLB107 26DLA500 26DLB085 26FLA287 26GLA058 26GLA968 26GLB068 DYNJ63392D UDI-DI 10198459164507 Lots 25ALA298 25BLA967 DYNJ908720B UDI-DI 10198459642517 Lots 26EBE658 DYNJ85189 UDI-DI 10195327473754 Lots 24AMA883
Where was it sold?
US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 99888This product is part of a recall event; the main page for the event is Convenience Kits containing Conmed AirSeal Access Ports recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Convenience Kits containing Conmed AirSeal Access Ports Chn recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Convenience Kits containing Conmed AirSeal Access Ports Kit recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
More recalls from Medline Industries
All 726| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Product Name Aud Open Heart Pack, Medline Kit Number recalled | Medline Industries | Packaging Defects | Nationwide |
Other Surgical Instruments recalls
All 3,902| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |
| Device | CLASS II | Perma-hand Silk Black Braided Sterile Nonabsorbable recalled by Ethicon | Ethicon | Packaging Defects | Nationwide |