MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST AB...
FDA Device Recall #Z-0519-2026 — Class II — September 30, 2025
Recall Summary
| Recall Number | Z-0519-2026 |
| 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 | 4214 kits |
Product Description
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.
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
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.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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-1564-2026 | Class II | Medline Surgical Drapes: MDTBTCS6070GN DBD-DRA... | Jan 28, 2026 |
| Z-1563-2026 | Class II | Medline Medcrest Surgical Gowns: MDTGXC4J5XL... | Jan 28, 2026 |
| Z-1463-2026 | Class II | Medline Kits containing Tego Connectors: Medli... | 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.