RecallRadar

FDA Device recall Z-1452-2025

Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I

On 2025-04-02 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I by Medline Industries Northfield, citing medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that ma….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1452-2025
ClassificationClass II
Statusongoing
Initiated2025-02-11
Published2025-04-02
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 6) ARTHROSCOPY TRAY, Pack Number DYNJ46435A; 7) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50120D

Reason

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Identifiers

code_info
1) Pack Number DYNJHS0101I: UDI/DI 10888277046412 (each) 40888277046413 (case), Lot Number 21LBA780A; 2) Pack Number…1) Pack Number DYNJHS0101I: UDI/DI 10888277046412 (each) 40888277046413 (case), Lot Number 21LBA780A; 2) Pack Number DYNJ0390808F: UDI/DI 10889942244591 (each) 40889942244592 (case), Lot Number 21JMG164A; 3) Pack Number DYNJ23150J: UDI/DI 10888277742239 (each) 40888277742230 (case), Lot Number 21LMF991A; 4) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case), Lot Number 22GBQ106M; 5) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case), Lot Number 22JBA123Z; 6) Pack Number DYNJ46435A: UDI/DI 10889942670901 (each) 40889942670902 (case), Lot Number 23LMG014A; 7) Pack Number DYNJ50120D: UDI/DI 10195327195656 (each) 40195327195657 (case), Lot Number 22JBG571Z

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1452-2025%22

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