| | 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-0519-2026 |
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| Recall Event ID |
97846 |
| Product Classification |
Plastic surgery and accessories kit - Product Code FTN
|
| Product | MEDLINE convenience kits labeled as:
1) ACH PLASTICS BREAST-LF, REF CDS983639K;
2) BREAST ABD, REF CDS984267J;
3) PLASTIC PACK, REF DYNJ00264M;
4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L;
5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M;
6) AUGMENTATION #87-RF, REF DYNJ27319V;
7) BREAST AUGMENTATION PACK, REF DYNJ33977M;
8) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M;
9) BREAST PACK, REF DYNJ57527C;
10) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G;
11) ISS MAJOR BREAST PACK, REF DYNJ58668D;
12) CHEST/BREAST PACK, REF DYNJ66495A;
13) MAJOR PLASTICS PACK, REF DYNJ67968B;
14) BREAST PACK, REF DYNJ68464A;
15) BREAST PACK, REF DYNJ68464B;
16) PLASTIC PACK, REF DYNJ83856;
17) PLASTIC PACK, REF DYNJ83856A;
18) PLASTIC PACK, REF DYNJ83856B;
19) BREAST PACK, REF DYNJ84332A;
20) ACH PLASTICS BREAST PK-LF, REF DYNJ85111;
21) BREAST-CHEST, REF DYNJ900294L;
22) PLASTICS MASTECTOMY, REF DYNJ904966C;
23) BREAST PLASTIC, REF DYNJ906638B;
24) BREAST-CHEST, REF DYNJ907141B;
25) BREAST RECONSTRUCTION PACK, REF DYNJ907791B;
26) BREAST RECONSTRUCTION PACK, REF DYNJ907791D;
27) BREAST HERNIA, REF DYNJ908058A;
28) CHEST BREAST KIT, REF DYNJ909203A;
29) PLASTIC, REF DYNJ909410;
30) PLASTIC, REF DYNJ910440;
31) BREAST -LF, REF DYNJ9426113N;
32) GP-PLASTIC BREAST ABD PACK-LF, REF PHS397064007D. |
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| Code Information |
REF CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23FBP157;
REF CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23GBM569;
REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 23LBN523;
REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24BBA266;
REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24CBS676;
REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24EBM454;
REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMA639;
REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMF507;
REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23GMI327;
REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23JMC006;
REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMA065;
REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMC367;
REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24DMF699;
REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24EMA236;
REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBI654;
REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBJ925;
REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23HBZ090;
REF DYNJ33977M: UDI/DI 10195327422523 (each), 40195327422524 (case), Lot Number 23HBB046;
REF DYNJ44852M: UDI/DI 10195327325220 (each), 40195327325221 (case), Lot Number 23HME689;
REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23GBA730;
REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23HBG731;
REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23HBT208;
REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23IBG463;
REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 23KMI230;
REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 24BME250;
REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 24DME657;
REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 23LMB473;
REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 24AMH995;
REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 24EMA379;
REF DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case), Lot Number 23DMG612;
REF DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case), Lot Number 23JMD696;
REF DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case), Lot Number 23IMG461;
REF DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case), Lot Number 24BMC283;
REF DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case), Lot Number 23LBN305;
REF DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case), Lot Number 24CBE964;
REF DYNJ68464B: UDI/DI 10195327666224 (each), 40195327666225 (case), Lot Number 24DBP960;
REF DYNJ83856: UDI/DI 10195327318253 (each), 40195327318254 (case), Lot Number 23GBV076;
REF DYNJ83856A: UDI/DI 10195327520830 (each), 40195327520831 (case), Lot Number 23LBD001;
REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24CBA468;
REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24CBJ818;
REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24EBC307;
REF DYNJ84332A: UDI/DI 10198459022432 (each), 40198459022433 (case), Lot Number 24EMI031;
REF DYNJ85111: UDI/DI 10195327460808 (each), 40195327460809 (case), Lot Number 23JBC629;
REF DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case), Lot Number 24CBI707;
REF DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case), Lot Number 24EBP322;
REF DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case), Lot Number 24IBK581;
REF DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case), Lot Number 24BBI057;
REF DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case), Lot Number 24CBA316;
REF DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case), Lot Number 24DBS660;
REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 23KBW113;
REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 24BBA200;
REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 24CBG796;
REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 24CBL477;
REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 23HBA138;
REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 23LBP102;
REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24ABO369;
REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24BBO672;
REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24CBL486;
REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24DBM827;
REF DYNJ907791B: UDI/DI 10195327185237 (each), 40195327185238 (case), Lot Number 23EBN537;
REF DYNJ907791B: UDI/DI 10195327185237 (each), 40195327185238 (case), Lot Number 23EBT257;
REF DYNJ907791D: UDI/DI 10195327439859 (each), 40195327439850 (case), Lot Number 23LBK712;
REF DYNJ907791D: UDI/DI 10195327439859 (each), 40195327439850 (case), Lot Number 24DBV324;
REF DYNJ908058A: UDI/DI 10195327125424 (each), 40195327125425 (case), Lot Number 24CBI553;
REF DYNJ908058A: UDI/DI 10195327125424 (each), 40195327125425 (case), Lot Number 24DBI370;
REF DYNJ909203A: UDI/DI 10195327363512 (each), 40195327363513 (case), Lot Number 24ABK735;
REF DYNJ909203A: UDI/DI 10195327363512 (each), 40195327363513 (case), Lot Number 24DBR411;
REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 23FMB748;
REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 23FMI603;
REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 23LMH380;
REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 24BMG608;
REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 24DMD838;
REF DYNJ910440: UDI/DI 10195327685973 (each), 40195327685974 (case), Lot Number 24EBJ004;
REF DYNJ9426113N: UDI/DI 10195327371449 (each), 40195327371440 (case), Lot Number 23KMI086;
REF DYNJ9426113N: UDI/DI 10195327371449 (each), 40195327371440 (case), Lot Number 23LMH856;
REF PHS397064007D: UDI/DI 10195327454111 (each), 40195327454112 (case), Lot Number 23HDB143. |
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| 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 | 4214 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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