FDA Device recall Z-1849-2026

Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F

FDA Device
Class II
ongoing
Published 2026-04-29

On 2026-04-29 the FDA classified a Class II recall of Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F by Medline Industries, citing the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1849-2026
Classification	Class II
Status	ongoing
Initiated	2026-02-25
Published	2026-04-29
Last updated	2026-09-13 11:58 UTC
Company	Medline Industries
Distribution	US

Product

Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272

Reason

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Identifiers

code_info	1) DYNJ32841F, UDI-DI: 10195327037796(each), 40195327037797(case), Lot Number: 24CBF407; 2) DYNJ46069D, UDI-DI: 1019348… 1) DYNJ32841F, UDI-DI: 10195327037796(each), 40195327037797(case), Lot Number: 24CBF407; 2) DYNJ46069D, UDI-DI: 10193489493184(each), 40193489493185(case), Lot Number: 24KBG704; 3) DYNJ51935A, UDI-DI: 10889942735549(each), 40889942735540(case), Lot Number: 24BME364; 4) DYNJ68902A, UDI-DI: 10193489870411(each), 40193489870412(case), Lot Number: 24BMC999; 5) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 22KBJ690; 6) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23BBD696; 7) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23DBG588; 8) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23FBD221; 9) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23GBN050; 10) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23IBB710; 11) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23LBM277; 12) DYNJ80679A, UDI

code_info

1) DYNJ32841F, UDI-DI: 10195327037796(each), 40195327037797(case), Lot Number: 24CBF407; 2) DYNJ46069D, UDI-DI: 1019348…

1) DYNJ32841F, UDI-DI: 10195327037796(each), 40195327037797(case), Lot Number: 24CBF407; 2) DYNJ46069D, UDI-DI: 10193489493184(each), 40193489493185(case), Lot Number: 24KBG704; 3) DYNJ51935A, UDI-DI: 10889942735549(each), 40889942735540(case), Lot Number: 24BME364; 4) DYNJ68902A, UDI-DI: 10193489870411(each), 40193489870412(case), Lot Number: 24BMC999; 5) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 22KBJ690; 6) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23BBD696; 7) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23DBG588; 8) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23FBD221; 9) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23GBN050; 10) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23IBB710; 11) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23LBM277; 12) DYNJ80679A, UDI

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1849-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.