Z-0640-2025Class II

MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF...

Name: Z-0640-2025 MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-10-09
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-09 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF... on 2024-10-09. FDA classified it as Class II and gives the reason as "Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0640-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-09
Posted: 2024-12-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, REF DYNJ0038440C; 8) NEURO PACK-LF, REF DYNJ0406347M; 9) NEURO-LF, REF DYNJ0484186M; 10) NEURO-LF, REF DYNJ0484186N; 11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K; 12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 13) NEURO-ORTHO EXTRAS, REF DYNJ44882L; 14) NEURO PACK, REF DYNJ57785B; 15) NEURO PACK, REF DYNJ60825B; 16) CHRISTUS MC NEURO PACK, REF DYNJ61157C; 17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C; 18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C; 19) AFCH SHUNT, REF DYNJ63317C; 20) NEURO SPINE PK, REF DYNJ63319D; 21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D; 22) DBS PACK, REF DYNJ63322A; 23) NEURO LAM, REF DYNJ64188B; 24) PACK,V-P SHUNT, REF DYNJ65472B; 25) NEURO PK, REF DYNJ66735A; 26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B; 27) NEURO PACK, REF DYNJ68558A; 28) NEURO PACK, REF DYNJ69019C; 29) VP SHUNT, REF DYNJ81866A; 30) VP SHUNT, REF DYNJ81866B; 31) VP SHUNT, REF DYNJ81866C; 32) NEURO PACK, REF DYNJ84058A; 33) NEURO, REF DYNJ900420O; 34) CRANIO / NEURO / SPINE, REF DYNJ901072G; 35) CRANIO / NEURO / SPINE, REF DYNJ901072I; 36) LAMINECTOMY, REF DYNJ903870F; 37) MINOR NEURO, REF DYNJ904859C; 38) MINOR NEURO, REF DYNJ904859D; 39) MINOR NEURO, REF DYNJ904859F; 40) NEURO, REF DYNJ904861B; 41) NEURO, REF DYNJ904861D; 42) NEURO, REF DYNJ904861F; 43) NEURO, REF DYNJ904861G; 44) KIT V P SHUNT, REF DYNJ908835A; 45) GENERAL NEURO, REF DYNJ909744
Product code: OJG Neurological Tray
Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Root cause tag: manufacturing process
FDA 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 in commerce: 12847 units
Distribution: US Nationwide distribution.
Product codes and lots: 84OJG 1) REF CDS780202P, UDI/DI 10195327096458 (each) 40195327096459 (case), Lot Numbers: 22IMA512, 22IMA513, 22FMD852, 22GME200, 22FMH471, 22LMA065; 2) REF CDS780202Q, UDI/DI 10195327265304 (each) 40195327265305 (case), Lot Numbers: 22LMA225, 23EME852, 23DME052; 3) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23FMI343, 4) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 22EBB662, 22JBR840, 23ABG194, 23DBM361, 23BBR105; 5) REF CDS981327Q, UDI/DI 10195327080365 (each) 40195327080366 (case), Lot Numbers: 22GMH480, 22FMF883, 22FMH830, 23JMG480, 23CMF104, 23BMH848, 23BMG193, 23BMG197, 23KMF371, 23IMG472; 6) REF CDS983186J, UDI/DI 10195327105624 (each) 40195327105625 (case), Lot Numbers: 23CBO871, 22EBV250, 22EBU143, 23DBA498, 23DBO557; 7) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23GMC512, 23GMC697; 8) REF DYNJ0406347M, UDI/DI 10195327510701 (each) 40195327510702 (case), Lot Numbers: 23JMH534; 9) REF DYNJ0484186M, UDI/DI 10195327046057 (each) 40195327046058 (case), Lot Numbers: 22EBF993, 22GBB271, 22FBF013; 10) REF DYNJ0484186N, UDI/DI 10195327204150 (each) 40195327204151 (case), Lot Numbers: 22JBX539, 22IBD332, 23FBB054, 23DBI625, 23GBL780; 11) REF DYNJ0843121K, UDI/DI 10195327286491 (each) 40195327286492 (case), Lot Numbers: 23IDC125, 23EDB879, 23DDB255, 23GDA826; 12) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 22EBN168, 22EBB079, 22HBY426, 22EBB077, 22IBS173, 22JBV775, 22JBW872, 23ABK720, 23ABB556; 13) REF DYNJ44882L, UDI/DI 10195327127725 (each) 40195327127726 (case), Lot Numbers: 22FDA475, 22LDA151, 22KDA751, 22HDA703, 23BDC150, 23ADB774, 22IDB866; 14) REF DYNJ57785B, UDI/DI 10195327072643 (each) 40195327072644 (case), Lot Numbers: 22GMF726, 22FMD430, 23AMF372, 23HMD358, 23JME934; 15) REF DYNJ60825B, UDI/DI 10195327521301 (each) 40195327521302 (case), Lot Numbers: 23KBE951, 23JBH391; 16) REF DYNJ61157C, UDI/DI 10195327470234 (each) 40195327470235 (case), Lot Numbers: 23IBP298; 17) REF DYNJ61168C, UDI/DI 10195327470197 (each) 40195327470198 (case), Lot Numbers: 23IBQ047; 18) REF DYNJ61174C, UDI/DI 10195327470203 (each) 40195327470204 (case), Lot Numbers: 23ILA859, 23HLB095; 19) REF DYNJ63317C, UDI/DI 10195327273446 (each) 40195327273447 (case), Lot Numbers: 23AMG481, 23BMC514, 23JMG245; 20) REF DYNJ63319D, UDI/DI 10195327402167 (each) 40195327402168 (case), Lot Numbers: 23FMG396, 23KMI427; 21) REF DYNJ63321D, UDI/DI 10195327404154 (each) 40195327404155 (case), Lot Numbers: 23GMH332; 22) REF DYNJ63322A, UDI/DI 10193489958058 (each) 40193489958059 (case), Lot Numbers: 22FBX778; 23) REF DYNJ64188B, UDI/DI 10195327279721 (each) 40195327279722 (case), Lot Numbers: 22LBE618, 23BBD435, 23ABJ723, 22LBP476, 23FBR198, 23JBE272; 24) REF DYNJ65472B, UDI/DI 10195327303396 (each) 40195327303397 (case), Lot Numbers: 23AMI025, 22LMJ219, 23DMB323, 23JMJ552; 25) REF DYNJ66735A, UDI/DI 10195327504755 (each) 40195327504756 (case), Lot Numbers: 23KBC296, 23JBT150, 23KBL436, 24DBV652; 26) REF DYNJ66766B, UDI/DI 10195327286286 (each) 40195327286287 (case), Lot Numbers: 23HMH943; 27) REF DYNJ68558A, UDI/DI 10193489994926 (each) 40193489994927 (case), Lot Numbers: 22GBT930, 22JBN310, 22LBN425, 22LBE068, 23ABD982, 23FBG228, 23IBG968, 23GBE570; 28) REF DYNJ69019C, UDI/DI 10195327436674 (each) 40195327436675 (case), Lot Numbers: 23GBE293, 23JBL407, 23LBQ035; 29) REF DYNJ81866A, UDI/DI 10195327216467 (each) 40195327216468 (case), Lot Numbers: 22IMF886, 22LMF365; 30) REF DYNJ81866B, UDI/DI 10195327302252 (each) 40195327302253 (case), Lot Numbers: 23BMI434, 23BMC486; 31) REF DYNJ81866C, UDI/DI 10195327417109 (each) 40195327417100 (case), Lot Numbers: 23GMA996, 23HMF910, 23JMC277, 24BMA973, 24AMH042, 23KMF115, 23LMA617, 24EMC255, 24CMH446; 32) REF DYNJ84058A, UDI/DI 10195327358013 (each) 40195327358014 (case), Lot Numbers: 23DBB749; 33) REF DYNJ900420O, UDI/DI 10195327031688 (each) 40195327031689 (case), Lot Numbers: 22LBJ603, 23EBT299, 23EBN052, 23DBA431, 23DBD628, 23GBA726, 24BBK023, 23IBQ476, 23HBO727, 23JBW347, 23JBV912, 23LBI436, 24ABI190, 24DBD086; 34) REF DYNJ901072G, UDI/DI 10195327137540 (each) 40195327137541 (case), Lot Numbers: 22FMG228, 22FMG229, 22HME733; 35) REF DYNJ901072I, UDI/DI 10195327232580 (each) 40195327232581 (case), Lot Numbers: 23AMC161, 22LMB464, 22LMB450, 23CMC880, 23GMC001; 36) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers: 22KBF911; 37) REF DYNJ904859C, UDI/DI 10195327216603 (each) 40195327216604 (case), Lot Numbers: 22IMC571; 38) REF DYNJ904859D, UDI/DI 10195327247959 (each) 40195327247950 (case), Lot Numbers: 23BMI235, 23BMG396, 23BMD402, 23AMC121, 22JME888, 23CMF042; 39) REF DYNJ904859F, UDI/DI 10195327417116 (each) 40195327417117 (case), Lot Numbers: 23GMD960, 23HMI173, 23HMA500, 23FME591, 23IMG713, 23KMC264, 24EMC263, 24BMF111, 24AMD480, 23LMD169, 24CMH460; 40) REF DYNJ904861B, UDI/DI 10195327124786 (each) 40195327124787 (case), Lot Numbers: 22HMA130; 41) REF DYNJ904861D, UDI/DI 10195327247713 (each) 40195327247714 (case), Lot Numbers: 22LMD320, 22JMF457, 23CMB553, 23BMF721; 42) REF DYNJ904861F, UDI/DI 10195327416041 (each) 40195327416042 (case), Lot Numbers: 23JMI908, 23GMH228, 23FME592, 24CME226; 43) REF DYNJ904861G, UDI/DI 10198459004063 (each) 40198459004064 (case), Lot Numbers: 24FME276; 44) REF DYNJ908835A, UDI/DI 10195327546465 (each) 40195327546466 (case), Lot Numbers: 24AMA052, 24HMA162, 24GME380; 45) REF DYNJ909744, UDI/DI 10195327465636 (each) 40195327465637 (case), Lot Numbers: 23JLA320, 24ALA727

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0640-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0622-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0623-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0624-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0625-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0626-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0627-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0628-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0629-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0630-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0631-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0632-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0633-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0634-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0635-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0636-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0637-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0638-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0639-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0640-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0641-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0642-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0643-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0644-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0645-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0646-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0647-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0648-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05
Z-0649-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05

Product code OJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)