| | Class 2 Device Recall MEDLINE |  |
| Date Initiated by Firm | September 30, 2025 |
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| Date Posted | November 14, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0513-2026 |
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| Recall Event ID |
97846 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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| Product | 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. |
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| 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.
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Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
800-369-1704 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2025 and 10/6/2025 via email and mail. The notice explained the issue with the component, potential risk, and requested the following actions:
1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.
2. Please use the link and the information found in the notice to complete the response form. Please list the quantity of affected product in inventory on the form. Even if no affected product is in inventory, please complete and submit the form.
3. Upon receipt of the submitted response form, the customer account will receive over-labels to place on affected inventory, with instructions for the customer staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
4. For distributors or those who have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 5133 kits |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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