RecallRadar

FDA Device recall Z-0648-2025

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S

On 2024-12-11 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S 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

AgencyFDA Device
Recall numberZ-0648-2025
ClassificationClass II
Statusongoing
Initiated2024-10-09
Published2024-12-11
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BREAST PACK, REF DYNJ65808C; 8) OCULOPLASTY PACK, REF DYNJ81798A; 9) OPHTHO PLASTIC, REF DYNJ902256C; 10) OCULAR, REF DYNJ909065; 11) OCULAR, REF DYNJ909065A; 12) PLASTIC EYE, REF DYNJVB91043A

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 DYNJ27466S, UDI/DI 10195327350314 (each) 40195327350315 (case), Lot Numbers: 23DBA280; 2) REF DYNJ41207C, UD…1) REF DYNJ27466S, UDI/DI 10195327350314 (each) 40195327350315 (case), Lot Numbers: 23DBA280; 2) REF DYNJ41207C, UDI/DI 10195327353063 (each) 40195327353064 (case), Lot Numbers: 23GMD059, 23KMH083; 3) REF DYNJ43147G, UDI/DI 10195327167257 (each) 40195327167258 (case), Lot Numbers: 22FBX412, 22FBS940; 4) REF DYNJ63329D, UDI/DI 10193489958065 (each) 40193489958066 (case), Lot Numbers: 22EBR487, 22EBC473; 5) REF DYNJ63329F, UDI/DI 10195327270414 (each) 40195327270415 (case), Lot Numbers: 23GMC980, 23LME454, 23IME156; 6) REF DYNJ64138B, UDI/DI 10193489355284 (each) 40193489355285 (case), Lot Numbers: 22FME241; 7) REF DYNJ65808C, UDI/DI 10195327369064 (each) 40195327369065 (case), Lot Numbers: 23KMF753, 23FMG930; 8) REF DYNJ81798A, UDI/DI 10195327515898 (each) 40195327515899 (case), Lot Numbers: 24CBM729, 24CBC467; 9) REF DYNJ902256C, UDI/DI 10195327089368 (each) 40195327089369 (case), Lot Numbers: 22FDA445, 22HDA810, 23CDB064, 23HDB222, 23IDB778, 23FDB836;

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-0648-2025%22

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