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MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDA...

FDA Device Recall #Z-0513-2026 — Class II — September 30, 2025

Recall Summary

Recall Number Z-0513-2026
Classification Class II — Moderate risk
Date Initiated September 30, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries, LP
Location Northfield, IL
Product Type Devices
Quantity 5133 kits

Product Description

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.

Reason for Recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

1) CDS840261AB: UDI/DI 10195327104535 (each), 40195327104536 (case), Lot Numbers: 23FBF165, 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each), 40195327228126 (case), Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each), 40195327327829 (case), Lot Numbers: 23FBA013, 23FBH486, 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Numbers: 23GBT133, 23HBH924, 23HBL135, 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each), 40193489288606 (case), Lot Numbers: 23KBU348, 24ABB883, 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each), 40195327357284 (case), Lot Numbers: 23GDB197, 23GDB757. 7) DYNJ0421380P: UDI/DI 10195327084271 (each), 40195327084272 (case), Lot Numbers: 23DMI590, 23FMJ656. 8) DYNJ21877W: UDI/DI 10195327104542 (each), 40195327104543 (case), Lot Numbers: 23FBT682, 23GBF898, 23IBC645, 24ABR316. 9) DYNJ22350L: UDI/DI 10193489445251 (each), 40193489445252 (case), Lot Numbers: 23LBU055, 24BBQ300. 10) DYNJ27432AC: UDI/DI 10195327104511 (each), 40195327104512 (case), Lot Numbers: 23EBU150, 23GBF873, 23HBQ650, 23IBB637. 11) DYNJ37284K: UDI/DI 10195327401030 (each), 40195327401031 (case), Lot Numbers: 23IBP124, 23KBF938, 24ABS487. 12) DYNJ38175L: UDI/DI 10195327227906 (each), 40195327227907 (case), Lot Numbers: 23FLA915, 23ILA168. 13) DYNJ42921G: UDI/DI 10193489981384 (each), 40193489981385 (case), Lot Numbers: 23FBU282, 23IBT172. 14) DYNJ43207K: UDI/DI 10193489952926 (each), 40193489952927 (case), Lot Numbers: 23EME962. 15) DYNJ43214F: UDI/DI 10193489953077 (each), 40193489953078 (case), Lot Numbers: 23EMA158. 16) DYNJ44847I: UDI/DI 10195327127558 (each), 40195327127559 (case), Lot Numbers: 23HLA758, 23HLB101, 23LLA759. 17) DYNJ44857U: UDI/DI 10195327298067 (each), 40195327298068 (case), Lot Numbers: 23GBI967, 23GBQ950. 18) DYNJ44869K: UDI/DI 10195327127657 (each), 40195327127658 (case), Lot Numbers: 23GBI967, 23GBQ950, 23KMC104. 19) DYNJ44879K: UDI/DI 10195327282233 (each), 40195327282234 (case), Lot Numbers: 23DBI854, 23EBH319, 23GBT541. 20) DYNJ44886M: UDI/DI 10195327127749 (each), 40195327127740 (case), Lot Numbers: 23DBN895, 23EBU129, 23FBQ134, 23GBQ953, 23HBT951. 21) DYNJ50528M: UDI/DI 10195327129699 (each), 40195327129690 (case), Lot Numbers: 23EBA780, 23EBS770, 23GBT274. 22) DYNJ51038R: UDI/DI 10195327298258 (each), 40195327298259 (case), Lot Numbers: 23HBD834. 23) DYNJ56838F: UDI/DI 10195327277857 (each), 40195327277858 (case), Lot Numbers: 23GDA228, 23HDA839. 24) DYNJ56839D: UDI/DI 10195327277864 (each), 40195327277865 (case), Lot Numbers: 23GDA320. 25) DYNJ60548B: UDI/DI 10195327361761 (each), 40195327361762 (case), Lot Numbers: 23EBD777, 23IBS545, 23JBJ740. 26) DYNJ60783B: UDI/DI 10195327361846 (each), 40195327361847 (case), Lot Numbers : 23EBR616, 23GBW384, 23IBV398. 27) DYNJ61659A: UDI/DI 10193489929638 (each), 40193489929639 (case), Lot Numbers: 23HBI627. 28) DYNJ62097C: UDI/DI 10195327189839 (each), 40195327189830 (case), Lot Numbers: 23DBJ117, 23EBD473, 23HBQ663, 23IBB641. 29) DYNJ65039C: UDI/DI 10195327528256 (each), 40195327528257 (case), Lot Numbers: 24BMF955, 24CMB409, 24CME382, 24FMH176. 30) DYNJ66033B: UDI/DI 10195327680589 (each), 40195327680580 (case), Lot Numbers: 24EBA176. 31) DYNJ80609D: UDI/DI 10195327298296 (each), 40195327298297 (case), Lot Numbers: 23HBR318, 23HBZ183. 32) DYNJ81581B: UDI/DI 10195327379254 (each), 40195327379255 (case), Lot Numbers: 23EBO537, 23GBQ499, 23HBG425. 33) DYNJ81605: UDI/DI 10195327123888 (each), 40195327123889 (case), Lot Numbers: 23DBL829, 23EBI374, 23EBM656. 34) DYNJ81610B: UDI/DI 10195327398316 (each), 40195327398317 (case), Lot Numbers: 23EBA748, 23IBP506. 35) DYNJ82166: UDI/DI 10195327182564 (each), 40195327182565 (case), Lot Numbers: 23FDA955. 36) DYNJ82217: UDI/DI 10195327183585 (each), 40195327183586 (case), Lot Numbers: 23DDB931, 23HDA667. 37) DYNJ84017B: UDI/DI 10198459253089 (each), 40198459253080 (case), Lot Numbers: 25CMF132. 38) DYNJ85109: UDI/DI 10195327460594 (each), 40195327460595 (case), Lot Numbers: 23JBD986. 39) DYNJ85110: UDI/DI 10195327460792 (each), 40195327460793 (case), Lot Numbers: 23KBF140. 40) DYNJ85118: UDI/DI 10195327460730 (each), 40195327460731 (case), Lot Numbers: 23KBI277. 41) DYNJ85121: UDI/DI 10195327460853 (each), 40195327460854 (case), Lot Numbers: 23IBR236, 23JBC564. 42) DYNJ85637: UDI/DI 10195327528188 (each), 40195327528189 (case), Lot Numbers: 24CBL150. 43) DYNJ900293K: UDI/DI 10195327554064 (each), 40195327554065 (case), Lot Numbers: 24ABE610, 24BBT270, 24DBU219. 44) DYNJ900714C: UDI/DI 10193489951363 (each), 40193489951364 (case), Lot Numbers: 23FBL767, 23HBW562, 23JBF697. 45) DYNJ901066K: UDI/DI 10195327239282 (each), 40195327239283 (case), Lot Numbers: 23HBB464, 23HBC020, 23JBF553, 23JBW634. 46) DYNJ903042P: UDI/DI 10195327438388 (each), 40195327438389 (case), Lot Numbers: 23JBL424, 23LBL094, 24ABS138. 47) DYNJ905079F: UDI/DI 10195327209001 (each), 40195327209002 (case), Lot Numbers: 23GBV464, 23HBO354. 48) DYNJ905497B: UDI/DI 10193489951639 (each), 40193489951630 (case), Lot Numbers: 23GBB505, 23HBN192, 23JBV542, 23JBV684. 49) DYNJ906175B: UDI/DI 10195327480127 (each), 40195327480128 (case), Lot Numbers: 24FMI570. 50) DYNJ907105D: UDI/DI 10195327233624 (each), 40195327233625 (case), Lot Numbers: 23EBG144, 23EBT013, 23FBI805, 23FBQ992. 51) DYNJ907904A: UDI/DI 10193489992434 (each), 40193489992435 (case), Lot Numbers: 23JME513, 23KMD522. 52) DYNJ908820: UDI/DI 10195327185671 (each), 40195327185672 (case), Lot Numbers: 23JMG465, 23KMI460. 53) DYNJ908820A: UDI/DI 10195327546045 (each), 40195327546046 (case), Lot Numbers: 23LMH559, 24CMA145, 24DMF994, 24DMI666.

Other Recalls from Medline Industries, LP

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Z-1650-2026 Class II Puracol and Puracol Plus Collagen Wound Dressin... Feb 10, 2026
Z-1562-2026 Class II Medline Kits containing Cardinal Health s Aqua-... Jan 30, 2026
Z-1563-2026 Class II Medline Medcrest Surgical Gowns: MDTGXC4J5XL... Jan 28, 2026
Z-1564-2026 Class II Medline Surgical Drapes: MDTBTCS6070GN DBD-DRA... Jan 28, 2026
Z-1464-2026 Class II Medline Kits containing Tego Connectors Medlin... Jan 8, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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