FDA Device recall Z-0635-2025

Refer to RES or lead review memo for complete list of affected reference/catalog numbers

FDA Device
Class II
ongoing
Published 2024-12-11

On 2024-12-11 the FDA classified a Class II recall of Refer to RES or lead review memo for complete list of affected reference/catalog numbers by Medline Industries Northfield, citing medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0635-2025
Classification	Class II
Status	ongoing
Initiated	2024-10-09
Published	2024-12-11
Last updated	2026-09-13 11:57 UTC
Company	Medline Industries Northfield
Distribution	US

Product

Refer to RES or lead review memo for complete list of affected reference/catalog numbers

Reason

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Identifiers

code_info	1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860… 1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860040K, UDI/DI 10195327010447 (each) 40195327010448 (case), Lot Numbers: 22ELA276, 23ALB139, 23ELA269, 23CLB184, 22JLA300; 3) REF CDS980245X, UDI/DI 10193489848434 (each) 40193489848435 (case), Lot Numbers: 22GBS312, 22FBG764, 22KBJ856, 23BBG738; 4) REF CDS980566F, UDI/DI 10193489445442 (each) 40193489445443 (case), Lot Numbers: 22HBJ660, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (

code_info

1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860…

1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860040K, UDI/DI 10195327010447 (each) 40195327010448 (case), Lot Numbers: 22ELA276, 23ALB139, 23ELA269, 23CLB184, 22JLA300; 3) REF CDS980245X, UDI/DI 10193489848434 (each) 40193489848435 (case), Lot Numbers: 22GBS312, 22FBG764, 22KBJ856, 23BBG738; 4) REF CDS980566F, UDI/DI 10193489445442 (each) 40193489445443 (case), Lot Numbers: 22HBJ660, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (

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-0635-2025%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.