FDA recall Z-2712-2024

Product

Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSCOPY-ROBOT, REF DYNJ905003C; h) ROBOTIC, REF DYNJ907156A

Reason for recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Distribution

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Key facts

Status

Ongoing

Initiation date

2024-03-22

Report date

2024-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2712-2024