Class II FDA device recall · Z-0513-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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.

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution.

Recall record

Recalling firm: Medline Industries, LP
Product type: Devices
Recall number: Z-0513-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2025-09-30

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0513-2026 · Source: openFDA enforcement.