Z-2712-2024 Class II Ongoing
FDA device recall Z-2712-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 22, 2024 and is designated Class II. Reason for recall: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. The recall status is ongoing. Affected quantity: 964 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2024
- Initiation Date
- Mar 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 964 units
Product Description
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 Pattern
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Code Information
a) REF DYNJ905499B, UDI/DI 40195327316915 (case), 10195327316914 (unit), Lot Numbers: DYNJ905499B, DYNJ905499B, DYNJ905499B, DYNJ905499B; b) REF DYNJ909936, UDI/DI 40195327511204 (case), 10195327511203 (unit), Lot Numbers: 23JBI037, 23KBP829; c) REF DYNJ902371J, UDI/DI 40195327505821 (case), 10195327505820 (unit), Lot Numbers: 23JBU910, 23LBM411; d) REF DYNJ905509F, UDI/DI 40195327269082 (case), 10195327269081 (unit), Lot Numbers: 22LMF016, 23CMH468, 23FMC902; e) REF DYNJS2030F, UDI/DI 40195327386499 (case), 10195327386498 (unit), Lot Numbers: 23EDB982, 23HDA434, 23JDA055; f) REF DYNJ902384K, UDI/DI 40195327503988 (case), 10195327503987 (unit), Lot Numbers: 23KBR180; g) REF DYNJ905003C, UDI/DI 40195327316922 (case), 10195327316921 (unit), Lot Numbers: 23BBP719, 23BBR580, 23DBM969, 23EBT058, 23FBS331, 23GBS886, 23HBP436, 23JBB060, 23LBF305, 23LBP294; h) REF DYNJ907156A, UDI/DI 40193489970266 (case), 10193489970265 (unit), Lot Numbers: 22EME051, 22FMF571, 22GME222, 22KMF942, 22KMF944, 23AMG688, 23BMF088, 23IME181, 23KMF153
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2712-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026