MEDLINE INDUSTRIES, LP - Northfield: 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

Recall number

Z-0648-2025

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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

Status

Open, Classified

Initiated

2024-10-09

Posted

2024-12-05

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.

Quantity

1921 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

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; 10) REF DYNJ909065, UDI/DI 10195327260019 (each) 40195327260010 (case), Lot Numbers: 23CMB048, 23CMA495; 11) REF DYNJ909065A, UDI/DI 10195327460648 (each) 40195327460649 (case), Lot Numbers: 24IME711, 24HME507; 12) REF DYNJVB91043A, UDI/DI 10195327309541 (each) 40195327309542 (case), Lot Numbers: 22LDB968, 23JDC086, 23KDB345, 23FDA062, 24DDB815, 24FDB470

510(k) numbers

not on file

PMA numbers

not on file

Product code

OJK

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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